BEUDAMED
    FDA Enforcement Class II Terminated

    MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S

    Recall: Z-1345-2019 · Reported May 22, 2019

    Enforcement

    Recall Number
    Z-1345-2019
    Event ID
    82629
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Compass Health Brands (Corporate Office)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2019
    Initiation Date
    April 8, 2019
    Classification Date
    May 15, 2019
    Termination Date
    October 26, 2020
    Address
    6753 Engle Rd, Middleburg Heights, OH, 44130-7934, United States

    Description

    MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S

    Reason

    Product design change did not receive proper premarket clearance and lacks a 510 (k)

    Code Info

    All Serial Numbers/Lots

    Distribution

    Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada