Recently, the U.S. Food & Drug Administration initiated a Class I recall of GranuFlo and NaturaLyte dialysis products, manufactured by the Germany based Fresenius. It has been alleged that Fresenius misled doctors and patients, after an internal memo to the FDA came to light, in which the company acknowledged a link between GranuFlo and Naturalyte to elevated bicarbonate levels. Elevated bicarbonate levels can lead to cardiac arrest and or other heart related issues.
According to the FDA, in some cases the use of GranuFlo and Naturalyte can lead to a high serum bicarbonate level in patients undergoing hemodialysis, which may contribute to metabolic alkalosis, a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia. This can lead to cardiac arrest and ultimately, death.
Fresenius is the largest dialysis services and products company in the United States, owning thousands of dialysis clinics. Fresenius manufactures nearly all the medical products used in dialysis care, and treats more than a third of the more than 400,000 Americans who receive dialysis care.
With regard to their knowledge of the increased risk of cardiac arrest, Fresenius only provided the internal memo mentioned above to Fresenius doctors and dialysis facilities, not to doctors or clinics who were using their products, yet unaffiliated with Fresenius. Fresenius only came clean in March, 2012, after their November 4, 2011 internal memo was leaked to the FDA – meaning they withheld the information for over 4 months, exposing an untold number of patients to the risk of cardiac arrest.
If you or a loved one has been injured by one of these dialysis products, call us today to see if we can help. Don’t delay, as waiting too long can ultimately bar an otherwise viable claim.