GranuFlo is a dry acid product manufactured by Fresenius Medical Care and used during the dialysis process which is a method of removal of waste from the blood. Studies have shown that GranuFlo contains an ingredient that the body converts to a bicarbonate. Problems arise for dialysis patients when doctors prescribe a bicarbonate in addition to the use of GranuFlo, and do not account for the extra bicarbonate produced in the body by the use of GranuFlo. Some dialysis patients suffer from an overdose of bicarbonate that has been linked to cardiac arrest and death during dialysis treatment. Some studies suggest that cardiac events increase four to six times when GranuFlo is used in treatment. According to the New York Times, Fresenius reported over 900 cardiac arrests in their dialysis clinics. Fresenius failed to warn any of the independent dialysis clinics who used GranuFlo. The FDA announced an investigation into Fresenius’ failure to warn independent dialysis clinics as to the use of GranuFlo.
In 2012, the FDA issued a Class 1 recall of Fresenius’ GranuFlo Acid Concentrate due to serious health consequences which include:
- Cardiac Arrest
By 2018, a wave of lawsuits had followed the recall. There are still over 2,000 lawsuits pending. If you or a loved one suffered a serious health condition or died as a result of the use of GranuFlo, please contact our office today for a free consultation at 302-298-0370.