BEUDAMED
    FDA Enforcement Class II Ongoing

    CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,

    Recall: Z-2324-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2324-2021
    Event ID
    88308
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho8, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 25, 2021
    Initiation Date
    July 9, 2021
    Classification Date
    August 19, 2021
    Address
    2217 Plaza Dr, N/A, Rocklin, CA, 95765-4421, United States

    Description

    CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,

    Reason

    CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

    Code Info

    All Lots

    Distribution

    US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV, NJ, NY, OK, PA, SC, TN, TX, UT, VA.

    Quantity

    N/A