BEUDAMED
    FDA Enforcement Class II Terminated

    Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.

    Recall: Z-0784-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0784-2017
    Event ID
    75055
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ultroid Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2016
    Initiation Date
    October 19, 2016
    Classification Date
    December 17, 2016
    Termination Date
    December 11, 2019
    Address
    3140 W Kennedy Blvd Suite 103, N/A, Tampa, FL, 33609-3175, United States

    Description

    Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.

    Reason

    Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)

    Code Info

    ALL serial numbers and lot numbers sold since January 14, 2003.

    Distribution

    AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam

    Quantity

    52,084