FDA issues Class 1 recall for dialysis substance GranuFlo®
The FDA has issued a Class 1 recall—the most serious recall type—for GranuFlo® (“GranuFlo”), a substance used in dialysis, following a revelation that when the “dry acid concentrate” is incorrectly mixed into the dialysis solution, it significantly increases patients’ risk of heart attack. The agency also recalled a similar substance, NaturaLyte.
Granuflo’s manufacturer, Fresenius Medical Care, is not only the U.S.’s biggest dialysis-center operator, but also supplies many outside dialysis centers with products, including GranuFlo. The company learned about the danger of using GranuFlo improperly last year, and alerted doctors at its own clinics in November. Fresenius did not, however, inform doctors at other clinics of this severe risk to patients—until the FDA heard about it from an anonymous informant and launched an investigation. The agency issued the recall not long afterward.
Have you or a loved one received dialysis and suffered such side effects as low blood pressure, hypokalemia (low potassium), hypoxemia (low oxygen), hypercapnia (high carbon dioxide), cardiac arrhythmia or even cardiac arrest? The cause may have been negligent use of GranuFlo. Contact Hodes Milman Liebeck, LLP, for a free case evaluation. We’re aggressive personal injury and medical malpractice attorneys, serving all of California and Arizona. We have the experience to take on the medical industry and have achieved multi-million dollar verdicts and settlements for our clients.