According to recent reports, more than half of all dialysis patients in the United States have received either GranuFlo or NaturaLyte treatments. People treated with these widely used dialysis drugs are also six times more likely to suffer cardiopulmonary arrest and sudden cardiac arrest.
Due to the serious risks associated with GranuFlo and NaturaLyte, the FDA issued a Class 1 recall, the most severe of all recall categories. The Class 1 recall indicates that the use of these dialysis drugs imparts the “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death”. The company responsible for the manufacturing of GranuFlo and NaturaLyte, Fresenius Medical Care (FMC), has been notified by the U.S. Food and Drug Administration (FDA) that these popular dialysis treatments must be recalled immediately.
Fresenius Medical Care is the largest dialysis products and services manufacturer in the U.S., with more than 5,700 dialysis centers treating over 400,000 dialysis patients across the country.