GranuFlo and NaturaLyte
GranuFlo and NaturaLyte are acid concentrates diluted to become components of dialysate, which is used during hemodialysis treatment to neutralize acid build up in the blood. The Food and Drug Administration (FDA) has issued a Class 1 GranuFlo and NaturaLyte recall based on evidence that the products can cause severe side effects such as heart attack, metabolic alkalosis, and stroke. Class 1 recalls are the most severe form of recall issued by the FDA.
The March 2012 FDA recall was prompted by a leaked internal memo from GranuFlo and NaturaLyte manufacturer Fresenius Medical Care (FMC). The internal memo was sent to dialysis centers owned by FMC in November 2011 and highlighted the risks associated with elevated bicarbonate levels caused by GranuFlo and NaturaLyte products in dialysis treatments.
Fresenius reported that 941 patients had experienced sudden cardiac arrest within their dialysis facilities after receiving hemodialysis treatment with GranuFlo and NaturaLyte. Fresenius also warned that patients undergoing dialysis treatments with their acid concentrates 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 FMC.
GranuFlo and NaturaLyte side effects include low blood pressure (hypotension), myocardial infarction, stroke, metabolic alkalosis, and cardiopulmonary arrest. GranuFlo is a dry acid, while NaturaLyte is a liquid dialysate formulation.
If you or a loved one experienced side effects from dialysis 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.