Granuflo & Naturalyte Dialysis Recall

Recently, the U.S. Food and Drug Administration (FDA) has announced a Class I recall involving NaturaLyte and GranuFlo dialysis products. Representing the most serious type of recall, a Class I recall means that something about these products represents a significant danger to people who are currently using them. When the FDA issues a Class I recall on any kind of medical device or product, patients for whom doctors prescribed the device or product should immediately discontinue using the product.

More about the GranuFlo and NaturaLyte Dialysis Recall

Why are NaturaLyte and GranuFlo Being Recalled?

Dangerously elevated levels of bicarbonate have been detected in patients using these products. An excessive amount of bicarbonate in the blood is known to be a serious risk factor for cardiac arrest.

As alkaline substances intended to work as acid neutralizers in dialysis patients, NaturaLyte and GranuFlo are administered concurrently with bicarbonate. In addition, NaturaLyte and GranuFlo products also contain another substance called acetate. Acetate assists the body in converting certain chemicals into more bicarbonate, which promotes accumulation of excessive amounts of bicarbonate in the body.

The FDA asserts that Fresenius Medical Care, makers of NaturaLyte and GranuFlo, neglected to inform doctors and patients of the serious risks involved when subjecting the body to their products’ effect to produce huge amounts of bicarbonate. Although the company discovered the dangers of its products early in 2011, it did not convey this information until people had died or suffered debilitating heart attacks as the result of using NaturaLyte and GranuFlo.

Symptoms Reported by Dialysis Patients

Thousands of people not only reported incidences of cardiac arrest, but also reported heart attacks, stroke, cardiopulmonary arrest and metabolic alkalosis. Ensuing research into the harmful effects of using NaturaLyte and GranuFlo found that patients using these products, even for a short period, were nearly significantly more likely to experience cardiac arrest than dialysis patients who were taking other brands of alkaline medications.

Compensation may be available for patients who have experienced the harmful effects of NaturaLyte and GranuFlo. Fresenius Medical Care currently is being sued by thousands of people who rightly deserve compensation for suffering serious health issues due to Fresenius’ failure to warn the public about the dangerous and even lethal consequences resulting from use of its defective product.

Additional Resources:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm