Home > Practice Areas > Prescription Medications and Recalled Medical Devices > GranuFlo and NaturaLyte
GranuFlo and NaturaLyte
Nearly half a million patients require dialysis at one of the 5,500 dialysis centers throughout the country. Fresenius Medical Care (FMC) is the largest owner and operator or dialysis centers around the world. It also manufactures many of the machines and drugs used in dialysis.
GranuFlo and NaturaLyte are medications that are made and administered by Fresenius and as well as other clinics and dialysis centers to cleanse blood of toxins and waste. GranuFlo and NaturaLyte’s contain both acetic acid and sodium acetate. When these chemicals are mixed improperly, they can cause dangerously high serum bicarbonate levels in patients undergoing hemodialysis. When sodium acetate converts into bicarbonate by the liver it can overdose the patient creating a higher risk for cardiac arrhythmia, heart attacks, cardiopulmonary arrest and death.
When FMC learned of GranuFlo’s danger and that over 940 deaths had been reported, it immediately issued a warning. But only to their company-owned clinics and not the thousands of independently-owned clinics, physicians and patients. As a result many continued to use GranuFlo and NaturalLyte.
A confidential memo was leaked to the FDA regarding FMC’s internal warning. In response, the FDA issued a Class 1 recall of both GranuFlo and NaturaLyte . Class 1 FDA recall is reserved for medical devices capable of causing serious medical complications or death.
If you or a family member or loved one are currently under dialysis or have suffered from cardiac arrest, heart attack, or other illnesses following dialysis and want to know if you have a case for a dialysis injury contact our office for a consultation regarding your legal rights. We are currently investigating claims against Fresenius for their failure to warn the public and hide the dangers of GranuFlo and NaturalLyte.
For more information, visit our blog post Dialysis Injury Lawsuits Against Fresenius