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GranuFlo and NaturaLyte Recall Lawsuit

GranuFlo® and NaturaLyte® are used in a majority of the dialysis centers currently operating in the United States. Distributed by Fresenius Medical Care, GranuFlo® and NaturaLyte® are dialysis treatment products used to treat acute and chronic renal failure. Fresenius Medical Care, also manufactures and sells dialysis machines and operates clinics using their own equipment and products.

In 2012, the U.S. Food and Drug Administration (FDA) issued a Class 1 recall, the most serious reacall that the FDA can order, for two products, NaturaLyte and GranuFlo acid concentrate. A Class 1 recall is reserved for situations where a drug or product could cause serious health problems or death.

In this case, the FDA did not actually direct dialysis clinics to remove the product from their shelves, only that Fresenius Medical Care North America (FMC) re-label GranuFlo and NaturaLyte and update the operating manuals for dialysis machines. The reason for this is that there are few alternative acid concentrates available. Some clinics have chosen to order acid concentrates from other manufacturers, but further incentives or mandates from the government doesn’t exist.

FMC did notify its own clinics via an internal memo about the risks associated with using NaturaLyte and GranuFlo if the dialysate was not prepared properly. The New York Times reported that, according to this memo, at least 941 people suffered sudden cardiac arrest while undergoing dialysis treatment on with thier products. Unfortunately FMC failed to warn doctors and staff at non-FMC dialysis facilities it was supplying with product in a timely manner about the issue, which resulted in injuries due to incorrect formulations of dialysate that could have been avoided.

Popular Dialysis Drugs GranuFlo and NaturaLyte Cause Serious Injuries & Side Effects

GranuFlo® and NaturaLyte® have been linked to heart attack, heart problems, cardiopulmonary arrest, low blood pressure, metabolic alkalosis, stroke, and even death.

If you or someone you know used GranuFlo® and suffered a heart attack, please fill out the form to the right or call our offices directly to set up to have your case evaluated for free.

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