BEUDAMED
    FDA Recall Terminated

    MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S

    Recall: Z-1344-2019 · Initiated April 8, 2019

    Recall

    Recall Number
    Z-1344-2019
    Event Number
    82629
    Firm
    Compass Health Brands (Corporate Office)
    FEI Number
    3012316249
    Product Code
    JOW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 8, 2019
    Terminated
    October 26, 2020
    Address
    6753 Engle Rd, Middleburg Heights, OH, 44130-7934

    Description

    MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S

    Reason

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

    Action

    On April 8, 2019 Compass Health issued URGENT MEDICAL DEVICE RECALL notices and Response Forms to customers via courier service. Customers were advised to take the following actions: 1) Ensure all affected personnel are fully informed of this notice. Forward the notice to the Regulatory Compliance Manager, Purchasing Manager, Customer Service Manager and Field Technicians. 2) Advise impacted customers regarding this recall. 3) Immediately check your stock for the model numbers and quarantine all affected product 4) Complete and return the Recall Response Form within fifteen (15) days of receipt of the notice via email to [email protected] or via fax to 440-268-2116. Customer with questions may call Compass Health Brands Corp. Customer Support at (800) 376-7263 Monday-Friday 8:00 am EST 5:00 pm EST.

    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