What is GranuFlo®?
GranuFlo® (and similar product NaturaLyte®) is a dialysis treatment used in clinics across the United States. It is manufactured by Fresenius Medical Care. These Naturalyte® and Granuflo® Dry Acid Concentrates are used in the treatment of acute and chronic renal failure during hemodialysis. The concentrates are formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.
According to the FDA, the manufacturer cautioned clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte® Liquid and Granuflo® Dry Acid Concentrate. Inappropriate prescription of these products, the FDA stated could lead to a high serum bicarbonate level in patients undergoing hemodialysis.
This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.
In March 2012, the FDA issued a Class I recall of GranuFlo® and NaturaLyte®. A Class I recall is the most serious and is issued only when “reasonable probability that the use of or exposure to the product will cause serious negative health consequences or death.” The FDA determined that GranuFlo® was too unsafe to remain on the market any longer.
If you, or someone you love, has suffered a heart attack or if you have lost a family member to sudden cardiac event after undergoing dialysis, we can help. Contact the McDivitt Law Firm. Click here for a free case evaluation form or call toll-free 877-846-4878. Our experienced attorneys will work closely with you and fight for the maximum compensation on your behalf.