GranuFlo & NaturaLyte Recall

The Nature of the Drug: GranuFlo and NaturaLyte are agents used in kidney-dialysis machines to remove impurities from the blood of patients with malfunctioning kidneys. Both products contain bicarbonate. GranuFlo is a powder, NaturaLyte is a liquid, but they perform the same function, which is help clean the blood of patients suffering kidney problems that prevent blood from being cleaned naturally. Kidney-dialysis centers exist because without dialysis, the buildup of waste products can be fatal. The usual remedy for failing kidneys is a transplant, but while awaiting a transplant a patient needs dialysis.

GranuFlo and NaturaLyte were widely used in kidney-dialysis centers for many years. One company has been most closely associated with both products. Fresenius Medical Care, based in Massachusetts, is one of the largest hemodialysis-clinic operators in the United States, and is also the leading supplier of dialysis products in the country. It made regular use of GranuFlo and NaturaLyte in its own clinics, though many other clinics also used the products.

The Hazards of GranuFlo and NaturaLyte: The risks of being treated with GranuFlo and NaturaLyte are sudden cardiac arrest, stroke, and cardiovascular death. The risks are so serious that in 2012, the FDA issued a Class 1 recall order, citing the risk of low blood pressure leading to heart attack, to other heart problems, or to death. Those health risks stem from bicarbonate buildup in the patient’s blood.

Many other health risks are associated with GranuFlo and NaturaLyte, including stroke, confusion, and arrhythmia.
Since GranuFlo and NaturaLyte’s health risks became evident several years ago, thousands of dialysis patients have filed lawsuits. Fresenius Medical Care has since settled a massive class-action suit, but other companies that used the products may still be liable.

To Obtain Legal Relief: Persons who were injured by their exposure to either GranuFlo or NaturaLyte during dialysis may have valuable legal rights. Attorney Stephen A. Katz is available at (800) 251-3529 for a free consultation, or for legal representation.