BEUDAMED
    FDA Enforcement Class II Terminated

    Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, SEKILTC, SEKILT*F, SEKILT*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    Recall: Z-2118-2019 · Reported August 7, 2019

    Enforcement

    Recall Number
    Z-2118-2019
    Event ID
    83144
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Burlington Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 7, 2019
    Initiation Date
    June 7, 2019
    Classification Date
    July 30, 2019
    Termination Date
    April 28, 2023
    Address
    PO Box 3194, 3 Elmhurst St, Newport News, VA, 23603-1137, United States

    Description

    Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, SEKILTC, SEKILT*F, SEKILT*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

    Reason

    The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.

    Code Info

    Serial Numbers: 387197 384398 387814 418788 419871 387879 385725 385749 385732 387887 382947 419840 418873 423988 385738 387937 444696 418901 381799 419884 379705 386112 416433 415529 443261 418973 419967 419814 423980 419787 419892 391089 391128 385744 379537 417552 414129

    Distribution

    US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.

    Quantity

    37