BEUDAMED
    FDA Enforcement Class II Ongoing

    Foundation Kit

    Recall: Z-0130-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0130-2022
    Event ID
    88656
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stradis Medical, LLC dba Stradis Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 27, 2021
    Initiation Date
    September 10, 2021
    Classification Date
    October 16, 2021
    Address
    3025 Northwoods Pkwy, N/A, Peachtree Corners, GA, 30071-1524, United States

    Description

    Foundation Kit

    Reason

    Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

    Code Info

    Part Number: A10

    Distribution

    Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.

    Quantity

    790 kits