Fresenius Medical Care North America(FMCNA), a Massachusetts based company, will voluntarily recall 56 lots of NaturaLyte┬« Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines). The products were recalled because they could develop harmful levels of bacteria during their shelf life. The bacteria in the solution has been identified as Halomonas (species 1, 2, 3), a Gram Negative bacteria.… Read More

The FDA has issued a Class I recall of dialysis concentrates GranuFlo andNaturaLyte because the products could put patients at risk for heart attacks and other serious cardiovascular problems. These products would have been administered to dialysis patients being seen in facilities run by or supplied by Fresenius Medical Care North America, the manufacturer of GranuFlo & NaturaLyte.… Read More