On March 29, 2012, the German company Fresenius Medical Care sent a memo to its customers advising them that its dialysate product GranuFlo might cause heart attacks and other side effects. In late June 2012, the U.S. Food and Drug Administration (FDA) classified Fresenius’s memo as a class I recall, the FDA’s most significant kind.
Metabolic Alkalosis Risk Cited as Cause For Recall
According to the FDA’s GranuFlo recall announcement, when used to treat people with kidney ailments, excess doses of GranuFlo can lead to high levels of serum bicarbonate, an alkaline chemical. Because the human body must maintain a certain pH balance to function properly, excess bicarbonate can cause a condition called metabolic alkalosis, which in turn can cause “low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest.”
The recall affects GranuFlo products that Fresenius manufactured and distributed between January 2008 and June 2012.
RLG’s GranuFlo Lawyers Will Advocate for You
If you received recalled GranuFlo as part of your hemodialysis treatment and believe it caused an injury, you might be entitled to compensation from the manufacturer. Submit this simple secure form for a free and confidential evaluation of your eligibility to file a GranuFlo lawsuit. The Rottenstein Law Group will consult with you for free, possibly filing a lawsuit on your behalf and keeping you up to date on any GranuFlo class action lawsuits, new FDA GranuFlo warnings, and additional GranuFlo FDA recall announcements. You will not be charged a penny until you receive compensation for your injurues.