FDA’s Class I Recall of GranuFlo & Nauralyte Dialysis ProductsThe U.S. Food & Drug Administration (FDA) has announced a Class I recall for Fresenius Medical Care’s NaturaLyte and GranuFlo dialysis products because of their association with life-threatening cardiac arrest events. A Class I recall is the FDA’s most serious recall category, and is issued […]
FDA’s Class I Recall of GranuFlo & Nauralyte Dialysis ProductsThe U.S. Food & Drug Administration (FDA) has announced a Class I recall for Fresenius Medical Care’s NaturaLyte and GranuFlo dialysis products because of their association with life-threatening cardiac arrest events. A Class I recall is the FDA’s most serious recall category, and is issued for products that pose risk of serious injury or death.
Earlier this month, the New York Times reported that dosage errors involving GranuFlo and NaturaLyte have been implicated in more than 900 cases of cardiac arrest at Fresenius-owned dialysis clinics. Both GranuFlo and NaturaLyte are administered to dialysis patients 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. Cardiac arrest can occur if a prescribing doctor does not account for the higher bicarbonate contribution from GranuFlo or NaturaLyte.
On November 4, 2011, Fresenius issued a memo to its own clinics late last year warning them of the potential risks associated with the two products. According to the document, 941 hemodialysis patients experienced cardiac arrest at 667 Fresenius facilities in 2010. An analysis the company conducted indicated that excess bicarbonate, or alkalosis, significantly increased the risk of heart problems in hemodialysis patients.
No similar warning was issued to any of the Fresenius customer clinics that use NaturaLyte or GranuFlo until March of this year. According to the Times, Fresenius only acted after the FDA started asking questions following its receipt of a copy of the November memo from an anonymous source.
According to the Times report, the FDA is now investigating Fresenius to determine if it violated federal regulations by failing to inform its customer clinics about the potentially risk of heart attack and sudden death associated with GranuFlo and NaturaLyte.
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