FDA Issues Recall for GranuFlo and NaturaLyte Dialysis Products
by: Melissa L. Stuart, Attorney
Chronic kidney failure affects more than 400,000 Americans. When the kidneys can no longer rid the body of toxins in the blood, patients will require dialysis until a transplant can be performed. Dialysis takes the place of the kidneys by filtering harmful wastes, extra salts, and fluids from the blood. Patients undergo dialysis treatment several times a week at clinics and hospitals. This treatment uses a solution of chemicals in conjunction with an external filter to purify the blood.
GranuFlo, is the brand name of a popular concentrate used in dialysis by a majority of the clinics and hospitals that offer treatment. The FDA recently issued a Class I recall on GranuFlo and NaturaLyte, which are two dialysis products manufactured by Fresenius and used in over 1,800 of its clinics and sold to hospitals and other dialysis clinics. Class I recalls are the most serious type of FDA product recalls and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences and death. Patients and doctors should take proper precautions to ensure their safety regarding these products.
The recall was ordered based on information provided to the FDA regarding an internal memo that Fresenius circulated to its own physicians and network of clinics. The memo stated that Fresenius had knowledge that there was a significant increased risk of sudden cardiac arrest and death associated with the use of GranuFlo during dialysis treatments. The memo reported 941 patients in 667 Fresenuis Medical Care facilities in 2010 had cardiac arrests during or soon after treatment.
Sudden cardiac arrest and other heart problems can occur when someone has an elevated level of bicarbonate in their blood. Bicarbonate is a central part of dialysis treatment. GranuFlo, because it is a powder, has a higher concentration of the chemical that produces bicarbonate during dialysis. This means that patients who had GranuFlo as part of their dialysis treatment solution were getting double the amount of bicarbonate, increasing their risk for heart problems.
More information about GranuFlo and NaturaLyte can be found here. If you or someone you know has experienced sudden cardiac arrest or if someone has died following dialysis using GranuFlo, please contact Cohen & Malad, LLP here or call 1-866-446-7478 to speak to one of our experienced product liability/personal injury attorneys to discuss your legal options and help you seek the compensation you deserve.