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FDA recall of GranuFlo and Naturalyte

Posted in Drugs, Granuflo & Naturalyte

On May 29th, 2012 the U.S. Food and Drug Administration issued a Class 1 recall of Fresenius Medical Care’s GranuFlo and Naturalyte, products used to clean and filter the blood in patients undergoing hemodialysis for chronic kidney failure.  As reason for the recall, the FDA writes:

“Inappropriate prescription of these products can 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 health consequences, including death.”

Read the rest of the FDA recall of GranuFlo and Naturalyte here.