Fresenius Medical Care North America clarified the class II recall of its 2008 Series dialysis machines. FMCNA told NN&I that, in November 2013, it notified customers that it had received reports of the saline bag on its hemodialysis machines inappropriately filling during priming and recirculation of the extracorporeal circuit.
FMCNA said it had vetted the customer notification with the FDA and then began the voluntary process of sending this notification to its hemodialysis machine customers and patients. The FDA classified this voluntary product notification as a Class II Recall. FMCNA said it has partnered with the FDA on this action to include keeping the product in the field. This classification does not involve removing any of our products from the market. FMCNA hemodialysis machines continue to be safe and effective when used in accordance with all product labeling, the company said.
This matter appears to be limited to situations where occlusions of the dialysis machine’s drain line in combination with an active internal Filling Program may push dialysate into the saline bag during recirculation if the saline line is unclamped, the company said.