FDA Classifies Naturalyte and Granuflo Recall as Class I

A Class I recall of Fresenius Medical Care’s Naturalyte and Granuflo dialysis products was issued by the Food and Drug Administration (FDA).

Class I recalls are the most serious type of recall issued by the FDA and involve situations in which there is a reasonable probability that use of a product will cause serious adverse health consequences or death.

The two products under recall, Naturalyte and Granuflo Dry Acid Concentrate, are used in treating serious and chronic renal failure during hemodialysis. The concentrate is used with a three-stream hemodialysis machine, which is adjusted for acid and bicarbonate concentrates.

Fresenius issued the recall in March 2012, warning health care professionals to be aware of the concentration of acetate or sodium acetate contained in the products, according to an FDA press release.

Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may led to metabolic alkalosis, which is a significant risk factor linked with low blood pressure, hypokalemia, hypoxemia, hypercapina, and cardiac arrhythmia, which could end in cardiopulmonary arrest.

The New York Times reported earlier this month that the FDA is looking into whether Fresenius ran afoul of federal regulations after the company sent an urgent memo to its own dialysis centers last year in which it warned that failure to use GranuFlo properly may be linked to increased risk of cardiac arrests and death in patients. The company did not warn other dialysis centers or the public about the issue until March 2012 when the FDA asked about the memo.

If you or a loved one has been harmed by a dangerous drug, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you. For legal help, call (800) 581-6358.

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