GranuFlo Recall Help
The Food and Drug Administration (FDA) has issued a Class 1 recall of GranuFlo and NaturaLyte based on evidence that the dialysis products can cause serious side effects such as heart attack, stroke and sudden death. The March 2012 recall occurred after the FDA was presented with a leaked internal memo from GranuFlo and NaturaLyte manufacturer Fresenius Medical Care (FMC).
GranuFlo and NaturaLyte are acid concentrates that become components of dialysate, which is used during hemodialysis treatment to neutralize acid build up in the blood. GranuFlo is a dry acid and NaturaLyte is a liquid dialysate formulation.
In November 2011, Fresenius Medical Care sent an internal memo to physicians working in dialysis centers owned by FMC that warned of potentially fatal side effects associated with elevated bicarbonate levels in the blood caused by GranuFlo and NaturaLyte products. GranuFlo and NaturaLyte side effects include heart attack, low blood pressure, myocardial infarction, stroke, metabolic alkalosis and cardiopulmonary arrest.
In the memo, Fresenius reported that 941 patients had experienced sudden cardiac arrest within their dialysis facilities after receiving dialysis treatment with GranuFlo and NaturaLyte. Fresenius studies also found that patients undergoing dialysis treatments with their products are at a six times greater risk of suffering a heart attack or sudden cardiac death than patients using other dialysis products. The manufacturer failed to offer the same warning to thousands of physicians and clinics not owned by Fresenius Medical Care.
If you or a loved one experienced a heart attack, stroke, or other side effects from 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.