Amid GranuFlo lawsuits alleging patients were harmed by the use of Fresenius Medical Care's GranuFlo product comes news that Fresenius has now recalled certain dialysis machines. Fresenius made the news in 2012, when the US Food and Drug Administration (FDA) received a leaked memo, indicating issues with the labeling on GranuFlo and NaturaLyte dialysate products.
In a letter to dialysis clinics dated November 4, 2013, Fresenius noted that it had "received reports of the saline bag inappropriately filling during recirculation of the extracorporeal circuit." The company said it was investigating the reports. According to the letter, there have so far been no deaths or other serious injuries linked to problems with the dialysis machines.
The letter noted that the machines must be installed and operated in compliance with the operator's manual. Although the action is considered a Class II recall, according to Nephrology News (1/17/14), no products were actually being removed from the market, rather they were the subject of a voluntary product notification. The FDA was aware of the company's actions. To read the entire article click here.