BEUDAMED
    FDA Enforcement Class II Terminated

    Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M

    Recall: Z-2115-2019 · Reported August 7, 2019

    Enforcement

    Recall Number
    Z-2115-2019
    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

    Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M

    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: 385688 387953 385694 385696 387781 384424 382874

    Distribution

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

    Quantity

    7