In 2012 the FDA recalled GranuFlo and NaturaLyte products and declared them a Class 1 recall — a class 1 recall indicates that “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
GranuFlo and NaturaLyte products are manufactured and sold by the largest dialysis provider in the United States, Fresenius Medical Care. Fresenius not only used the product in their dialysis center but also sold it to dialysis treatment centers throughout the country.
The cocktail drug is made by mixing Granuflo, a powder concentrate, with its liquid counterpart, NaturaLyte, used to neutralize the normal buildup of acid in the blood stream.
According to a company memo that was later leaked to the New York Times, stated that 941 patients that treated at Fresenius’ own dialysis centers experienced cardiac arrest during 2010. After knowing this, they still continued to sell the deadly product. This warning memo was only sent to its own doctors and despite the fact that 100,000 + dialysis patient were receiving the deadly duo at non Fresenius centers.
On March of 2013 lawsuits filed in federal court were consolidated to the US Federal Court in Massachusetts. As of January 2015 thousands of lawsuits have been filed against Fresenius by victims and their families.