Granuflo / NaturaLyte
Fresenius Medical Care (FMC) manufactures GranuFlo and NaturaLyte, as well as many of the machines and products used in dialysis treatments. FMC is also one of the largest dialysis clinic operators in the world.. In 2011, FMC issued an internal notice to its company-owned clinics, warning of the risks and side effects of the products; however, they failed to offer warnings to thousands of physicians and clinics not owned by FMC who continued to use their product.
As a result of the memo leaked to the U.S. Food and Drug Administration in 2012, the FDA issued a Class 1 recall of all GranuFlo and NaturaLyte products. If you or a loved one is undergoing dialysis, take these steps immediately:
This makes correct acid and bicarbonate levels absolutely essential. Incorrectly mixed dialysate that results in increased bicarbonate levels can place patients at an increased risk of metabolic alkalosis —a dangerous GranuFlo side effect.
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The FDA has requested Fresenius Medical Care to issue a Naturalyte Liquid Acid Concentrate recall and a Naturalyte GranuFlo recall after receiving a complaint about alkali dosing errors.