Fresenius Medical Care North America Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius USA Inc., Walnut Creek, CA Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.