BEUDAMED
    FDA Enforcement Class II Terminated

    Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

    Recall: Z-1782-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1782-2021
    Event ID
    87808
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CLINICAL LASERTHERMIA SYSTEMS AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 9, 2021
    Initiation Date
    April 1, 2021
    Classification Date
    June 3, 2021
    Termination Date
    August 30, 2023
    Address
    Scheelevagen 2, Lund, N/A, Sweden

    Description

    Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

    Reason

    single use devices labeled as sterile may not have been adequately sterilized

    Code Info

    Lot # 00247/2019/11, 00029/2020/02, 00076/2020/03, 00177/2018/10-1, 00177/2018/10-2, 00049/2020/02

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of TX, MD, CA and the countries of Canada, Germany, Switzerland.

    Quantity

    90 units