The products Granuflo® and Naturalyte®, used in dialysis treatment for acute renal (kidney) failure, has had a Class I recall issued by the Food and Drug Administration (FDA) as of March 29, 2012. A class I recall, the most serious type of recall, is used for products with a high probability of serious adverse consequences or death.
Both of these products are manufactured by Fresenius Medical Care (FMC) and distributed through their subsidiary, Fresenius Medical Care North America. The company is still producing the products, but has issued notifications to its customers regarding the prescribed use of the product due to the possibility of serious side effects, including low blood pressure, cardiac arrhythmia, and cardiac arrest leading to death.
In the hemodialysis process, which is a partial replacement for kidney function, a patient’s blood is pumped through a device called a dialyzer, and mixed with dialyzer fluid which, in conjunction with a membrane, filters waste products normally filtered by a healthy kidney, from the bloodstream. The blood is then returned to the patient’s body. Granuflo®, a dry acid, and Naturalyte®, a liquid dialysate, are mixed with other treatment fluids before being used in this process.
It is estimated that use of these products can increase the possibility of cardiopulmonary arrest and sudden death up to 6 times the normal risk associated with dialysis.