Class 1 GranuFlo and NaturaLyte Recall
The Food and Drug Administration (FDA) has issued a Class 1 recall of GranuFlo and NaturaLyte acid concentrates used during hemodialysis treatment. The recall occurred after an internal memo sent by Fresenius Medical Care (FMC), the manufacturer of GranuFlo and NaturaLyte, was leaked to the FDA.
Class 1 recalls are the most severe form of recall issued by the FDA and occur in situations where there is reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.
The Fresenius Medical Care internal memo that sparked the FDA’s Class 1 recall reported that 941 patients had died from sudden cardiac arrest in FMC dialysis clinics after receiving treatment with GranuFlo and NaturaLyte. The memo also stated that use of GranuFlo and NaturaLyte can increase the risk of heart attack by 6 times in dialysis patients with high bicarbonate levels in the blood.
Fresenius Medical Care sent this warning to their own dialysis centers, but did not send the warning to thousands of physicians at dialysis clinics not owned by FMC. GranuFlo and NaturaLyte concentrates were manufactured and distributed from January 2008 through June 2012.
If you or a loved one experienced cardiac arrest, stroke or other serious side effects after receiving hemodialysis treatment with GranuFlo or NaturaLyte, contact the dialysis injury attorneys 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.