According to the FDA, Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of a product will cause serious adverse health consequences or death.
GranuFlo and NaturaLyte are alkaline substance administered to dialysis patients to neutralize the acid that builds up in the blood. The products are administered in conjunction with bicarbonate, and contain acetate, an ingredient that the body converts to bicarbonate. However, GranuFlo and NaturaLyte contain far more acetate than rival products, and thus result in more bicarbonate in the body.
What are GranuFlo and NaturaLyte?
GranuFlo® is the most-widely prescribed dry acid product used in dialysis treatment. Clinics that use GranuFlo are required to mix their own concentrations of the solution. NaturaLyte, also known as NaturaLyte Liquid Acid Concentrate, is a pre-mixed liquid solution.
Who manufactures GranuFlo and NaturaLyte?
Both products are manufactured and sold by the German company, Fresenius Medical Care (FMC).
What injuries are caused by GranuFlo and NaturaLyte?
In a memo published by the products’ manufacturer, Fresenius Medical Care, it was noted that 941 patients had suffered cardiac arrest in 667 FMC facilities in 2010 alone. (This does not include the number of patients that may have been injured or died in clinics not owned or operated by FMC.)
Talk to us if you are concerned that you or a loved one were hurt.