BEUDAMED
    FDA Recall Terminated

    Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes

    Recall: Z-0782-2017 · Initiated October 19, 2016

    Recall

    Recall Number
    Z-0782-2017
    Event Number
    75055
    Firm
    Ultroid Technologies, Inc.
    FEI Number
    3013037032
    Product Code
    KNS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 19, 2016
    Terminated
    December 11, 2019
    Address
    3140 W Kennedy Blvd, Suite 103, Tampa, FL, 33609-3175

    Description

    Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile 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)

    Action

    On October 19, 2016 Ultrid sent a recall letter to all their consignees informing them of the recall and to cease further distribution of this product, respond the self-addressed response form and returned for a voucher. For more information contact Melanie Rosario at 727-898-0717

    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

    1,129