BEUDAMED
    FDA Recall 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 · Initiated May 23, 2019

    Recall

    Recall Number
    Z-1957-2019
    Event Number
    82946
    Firm
    Richard Wolf Medical Instruments Corp.
    FEI Number
    1418479
    Product Code
    HIH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 23, 2019
    Posted
    June 13, 2019
    Terminated
    August 4, 2020
    Address
    353 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3110

    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.

    Action

    Richard Wolf Medical Instruments, Corp. notified customers on 05/23/2019 via "Urgent Safety Information: Recall" letter. Instructions included to examine distribution reports and stock immediately to determine if any affected devices are on hand, quarantine any affected devices, advise customers of the recall if affected devices were further distributed, and scrap all affected devices on site. Customers were also instructed to complete and return the Answer form provided with the notification letter. An updated "Urgent Safety Information: Recall" letter was sent via email on 06/07/2019 to customers. The letter contained an update to include the hazard and risk. Instructions to customers remained the same as in the original letter.

    Distribution

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

    Quantity

    5 boxes (5 electrodes each)