Fresenius Recalls Certain Dialysis Machines

Washington, DCAmid 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.

The situation is a far cry from the one that has resulted in hundreds of lawsuits being filed against Fresenius. Lawsuits are still reportedly being filed against the company, alleging patients were harmed by the use of GranuFlo and NaturaLyte, and further claiming that Fresenius knew about the risks associated with those products but failed to warn patients or the FDA.

That situation became public when the FDA received a leaked memo sent from Fresenius to its own dialysis centers - but not to other dialysis centers - warning that approximately 940 patients suffered cardiac arrest in 2010, after being exposed to GranuFlo. The letter was reportedly sent to Fresenius clinics in November 2011, but a voluntary recall was not announced until June 2012. Issues with GranuFlo and NaturaLyte reportedly involved dosing errors that could cause serious reactions that can lead to cardiopulmonary arrest and, in some cases, death.

As with the dialysis machines, the recall did not involve products being removed from the market, but did involve a label change.

Lawsuits have been consolidated in a federal multidistrict litigation. The MDL is In Re: Fresenius GranuFlo/Naturalyte Dialysate Litigation, MDL No. 2428.