Consumer Alert: Use of GranuFlo® and NaturaLyte® Dialysates Linked to Risk of Cardiac Arrest

August 17, 2012

GranuFlo® and NaturaLyte® are dialysates used during kidney dialysis to remove wastes from the blood of patients with acute or chronic renal failure.  The use of GranuFlo® and NaturaLyte® has been reported in some cases to lead to a blood condition called "alkalosis," which can lead to low blood pressure and even cardiac arrest [1]. 

On May 25, 2012, the United States Food and Drug Administration (FDA) released a Safety Communication instructing health care providers to be aware of fact that GranuFlo® and NaturaLyte® can deliver an excessive amount of bicarbonate into a patient's bloodstream [1]. 

On June 27, 2012, the FDA issued a Class 1 recall of GranuFlo® and NaturaLyte®.  A Class 1 recall is used when there is a reasonable probability the product will cause serious health consequences or death [2]. 

Robins Kaplan LLP is investigating cases involving GranuFlo® and NaturaLyte®.  If you or someone you know has suffered serious injury following hemodialysis with GranuFlo® or NaturaLyte® dialysate and you wish to consult with a lawyer, please call at 1-800-553-9910 or contact us.