Overview
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 arrest1.
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 bloodstream2.
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 death3.
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 1.800.553.9910 or contact us.
