BEUDAMED
    FDA Enforcement Class II Ongoing

    REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L

    Recall: Z-1398-2023 · Reported April 26, 2023

    Enforcement

    Recall Number
    Z-1398-2023
    Event ID
    91923
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Compass Health Brands (Corporate Office)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 26, 2023
    Initiation Date
    March 7, 2023
    Classification Date
    April 18, 2023
    Address
    6753 Engle Rd, N/A, Middleburg Heights, OH, 44130-7934, United States

    Description

    REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L

    Reason

    Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication

    Code Info

    UDI-DI: DVTREX-L: 00092237622933 DVTREX-U: 00092237622926 All Serial Numbers

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    30 units