The FDA has issued a Class I recall regarding the dialysis products GranuFlo and NaturaLyte. This is because patients are at risk of serious side effects that may result during or shortly after dialysis treatment using these products.

GranuFlo litigation is occurring in courts around the country, after hundreds of patients have suffered cardiopulmonary arrest, cardiac arrest, arrhythmia and death following the administration of GranuFlo and NaturaLyte during dialysis treatments. Granuflo and NaturaLyte are made by Fresenius Medical Care, a German company that owns the majority of dialysis clinics in the U.S.

The drug maker understood the health risks when the products were placed on the market.

GranuFlo and NaturaLyte are products used to help cleanse acid from the blood of dialysis patients. GranuFlo is the powder form of the drug, while NaturaLyte is the liquid form. However, both of these products are different from rival products in that they use sodium diacetate, which can lead to higher concentrations of bicarbonate. An overdose of bicarbonate can cause serious cardiac issues.

Fresenius’ choice of the dry acid product used in GranuFlo is also significant. The sodium diacetate formulation of GranuFlo was chosen because it can be shipped in a dry powder form. The other acid products need to be shipped as liquids. The only reason this GranuFlo formulation would be chosen is to save Fresenius shipping and handling costs – and not to improve patient outcomes or treatment efficacy.

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