BEUDAMED
    FDA Enforcement Class II Terminated

    E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.

    Recall: Z-1957-2019 · Reported July 17, 2019

    Enforcement

    Recall Number
    Z-1957-2019
    Event ID
    82946
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard Wolf Medical Instruments Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 17, 2019
    Initiation Date
    May 23, 2019
    Classification Date
    July 10, 2019
    Termination Date
    August 4, 2020
    Address
    353 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3110, United States

    Description

    E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.

    Reason

    E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03.

    Code Info

    Product Number: 8416.0305; Batch Number: 1390827; Expiration Dates 10/15/2023 and 03/11/2024

    Distribution

    US nationwide distribution in the states of South Carolina, Rhode Island, and Missouri.

    Quantity

    5 boxes (5 electrodes each)