BEUDAMED
    FDA Recall Terminated

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    Recall: Z-1213-2014 · Initiated June 26, 2013

    Recall

    Recall Number
    Z-1213-2014
    Event Number
    67517
    Firm
    Mar Cor Purification
    FEI Number
    3006475063
    Product Code
    FIP
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 26, 2013
    Posted
    March 14, 2014
    Terminated
    January 22, 2015
    Address
    14550 28th Ave N, Minneapolis, MN, 55447-4817

    Description

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    Reason

    High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.

    Action

    Mar Cor sent an Urgent Medical Device Correction letter dated March 5, 2014 to all affected customers. The letter identifies the affected devices, what the issue is and tells customers to contact Mar Cor to schedule correction. A response form was asked to be completed and returned. For questions contact Scott Nichols, Project Coordinator/Service Trainer at 1-800-633-3080.

    Distribution

    USA Nationwide Distribution including Puerto Rico.

    Quantity

    232 units