BEUDAMED
    FDA Recall Terminated

    Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA

    Recall: Z-2227-2010 · Initiated November 20, 2009

    Recall

    Recall Number
    Z-2227-2010
    Event Number
    54546
    Firm
    Fresenius Medical Care North America
    FEI Number
    3001451489
    Product Code
    FKP
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    November 20, 2009
    Posted
    August 15, 2010
    Terminated
    February 7, 2011
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA

    Reason

    Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.

    Action

    An urgent device recall notification was sent to all consignees. Customers are asked to inspect cords for defects, and are refered to preventive maintenance requirements in the manual. Customers who identify the defective cords will be instructed to discontinue use as soon as possible without jeopardizing patient care. Customers are instructed to monitor cords regularly, and pay attention to machines that are frequently plugged or unplugged. Personnel are instructed to not use the cord to unplug the device from the wall (yanking the plug from the wall) and to refrain from rolling over the cord or plug.

    Distribution

    Product distributed to 5404 customers throughout the US and the world.

    Quantity

    10267