BEUDAMED
    FDA Enforcement Class II Terminated

    1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111F, REF111*F, REF111*M, REF111B, REF111E, REF111F, SEF111*F, SEF111*M, SEF111C, SEF111D, SEF111E, SEF111F, UEF111*F, UEF111*M, UEF111A, UEF111B, UEF111C, UEF111D, UEF111E, UEF111XLM, UEF111XXLM 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-2111-2019 · Reported August 7, 2019

    Enforcement

    Recall Number
    Z-2111-2019
    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

    1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111F, REF111*F, REF111*M, REF111B, REF111E, REF111F, SEF111*F, SEF111*M, SEF111C, SEF111D, SEF111E, SEF111F, UEF111*F, UEF111*M, UEF111A, UEF111B, UEF111C, UEF111D, UEF111E, UEF111XLM, UEF111XXLM 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: 379682 379535 423744 423745 387796 426462 419802 384492 377568 379681 379690 379698 386085 377724 382991 384347 385884 386083 381755 379715 385640 381868 426861 426802 426955 426895 426634 426809 426951 416567 426461 426789 426952 381869 443767 443802 377712 381865 377711 382966 381899 381866 382876 387805 382949 385982 423502 339345 423501 414165 414167

    Distribution

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

    Quantity

    51