GranuFlo and NaturaLyte Recall
The Food and Drug Administration (FDA) has issued a Class 1 GranuFlo recall and NaturaLyte recall based on evidence that the dialysate acid concentrates can cause potentially fatal side effects such as heart attack and stroke when used during hemodialysis treatment. Class 1 recalls are the most severe form of recall issued by the FDA.
The GranuFlo recall occurred after an internal memo sent by Fresenius Medical Care (FMC), the manufacturers of GranuFlo and NaturaLyte, was leaked to the FDA. The manufacturer’s memo detailed the connection between the elevated bicarbonate levels caused by GranuFlo and NaturaLyte and cardiac arrest.
Fresenius Medical Care sent this internal memo to their own dialysis centers, but failed to offer the same warning to thousands of physicians at dialysis clinics not owned by FMC.
If you or a loved one experienced heart attack, stroke, cardiac arrest or other side effects after receiving hemodialysis treatment with GranuFlo or NaturaLyte, contact the lawyers at Hissey Kientz, LLP for a free case evaluation. You can reach us by calling toll-free at 1-866-275-4454, or by filling out our free contact form on the right of this page.