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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, Miller & Ciresi L.L.P. 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.
[1] http://www.fda.gov/Drugs/DrugSafety/ucm305630.htm
[2] http://www.fda.gov/Safety/Recalls/ucm165546.htm
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