Dialysis Products GranuFlo & NaturaLyte Under Class I Recall

Dialysis Products GranuFlo & NaturaLyte Under Class I Recall

By Christina Drury

After the FDA received reports outlining the dangers and adverse side effects caused by the use of the dialysis additives GranuFlo and NaturaLyte, a massive Class 1 recall was issued in 2012. Dialysis clinics all over the U.S. were informed of the risks linked to administering the incorrect dosage, which include heart attack, cardiac arrest and death.

The controversy that arose from the GranuFlo recall is that it was discovered that Fresenius, the company that manufactures the dialysis additives, was well aware of the dangers of GranuFlo heart attacks and had issued a warning to their internal network in 2011. However, Fresenius failed to inform dialysis clinics and customers outside of their network, which led to injuries and complications that may have been otherwise avoided. The internal memo from Fresenius was anonymously forwarded to the FDA four months after it was released, sparking an investigation into the drug manufacturer.
What is GranuFlo and NaturaLyte Used For?

It’s the kidney’s job to cleanse the body’s blood supply, but when the kidney fails, dialysis is a process that helps perform the same duties that the kidney can no longer complete. Those suffering from kidney failure undergo dialysis in order to continue living a normal and healthy life. GranuFlo and NaturaLyte are acid concentrated additives that are part of the dialysis process; however there is an ingredient present in these two products that converts to bicarbonate, which has the potential of creating a life-threatening situation for some patients.

Although bicarbonate is needed to help the body rid itself of toxins, an excess amount of bicarbonate from GranuFlo and NaturaLyte can lead to some very serious side effects. These side effects include cardiac arrest, low blood pressure, cardiac arrhythmia and metabolic alkalosis, which can lead to sudden death. In order to avoid this, patients must be closely monitored and immediately treated for their symptoms.

Fresenius Being Sued For Failure to Warn All Clinic Using Their Products

Although Fresenius came clean and issued a warning about the potential side effects of GranuFlo and NaturaLyte, for many patients it was too little too late. There are thousands of dialysis clinics that utilized GranuFlo and NaturaLyte, and those outside of the Fresenius network were not given the same courtesy of fair warning that clinics owned and operated by the manufacturer were given. When the warning of GranuFlo and NaturaLyte side effects was finally made public, there were already hundreds of patients who had suffered the severe side effects associated with GranuFlo and NaturaLyte. Despite the FDA’s decision to issue a Class 1 recall in order to have the products immediately removed from the market, numerous victims have chosen to file lawsuits against Fresenius.

Fresenius Recall Lawsuits Are Now Being Filed

Armed with the knowledge that Fresenius chose not to warn the general public about the risks of their GranuFlo and NaturaLyte products, many are now filing lawsuits against the company. If you or someone you know has used either of these dialysis products and have suffered side effects such as heart attack, cardiac arrest, low blood pressure, metabolic alkalosis or even death, you may be eligible to receive compensation. For more information on how to move forward with your lawsuit and to submit the details of your personal experience with the product, please visit our Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation page.