NaturaLyte and GranuFlo Recalls
You May be Eligible to File a GranuFlo Lawsuit in NJ
If you or someone you know has suffered cardiac arrest or sudden death while undergoing dialysis treatment, you may be eligible to file a lawsuit against GranuFlo in NJ.
GranuFlo and NaturaLyte are acid concentrates that are widely used during dialysis to help neutralize acid build up in the blood.
The Food & Drug Administration (FDA) issued a Class 1 Recall notice on June 27, 2012 for Fresenius Medical Care North America NaturaLyte Liquid Concentrate and NaturaLyte GranuFlo (powder) Acid Concentrate.
The FDA issued this recall because of the risk of high serum bicarbonate levels in patients undergoing hemodialysis. These high levels can contribute to metabolic alkalosis, which is a significant risk factor associated with cardiac arrest, stroke and sudden death.
The FDA worked with Fresenius Medical Care to release an Urgent Product Notification to Fresenius customers and clinics. It was officially released on March 29, 2012 and cautioned practitioners to be aware of the concentration of acetate or sodium diacetate in the products in the GranuFlo recall.
However, in 2011, prior to this Urgent Product Notification, Fresenius Medical Care sent an internal memo to practitioners working in Fresenius-owned dialysis centers warning of potentially fatal side effects linked to these two products. The memo reported that 941 patients treated in Fresenius dialysis centers had experienced sudden cardiac arrest after receiving treatment with these products.
The manufacturer failed to issue this warning publicly in a timely manner, putting thousands of patients at risk, and resulting in the GranuFlo recall lawsuits.