BEUDAMED
    FDA Enforcement Class II Terminated

    Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

    Recall: Z-0581-2019 · Reported December 19, 2018

    Enforcement

    Recall Number
    Z-0581-2019
    Event ID
    81519
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leoni Fiber Optics GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 19, 2018
    Initiation Date
    October 17, 2018
    Classification Date
    December 7, 2018
    Termination Date
    April 10, 2020
    Address
    Muhldamm 6, N/A, Neuhaus-Schierschnitz, N/A, N/A, Germany

    Description

    Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

    Reason

    A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartscope single-box packaging are at risk of a compromised product seal. Broken seal pouches compromise sterility and could increase the risk of infection if used.

    Code Info

    096975 00816901020326

    Distribution

    US Distribution to the state of: Ohio.

    Quantity

    N/A