Fresenius Medical Care North America’s (FMCNA) recall of 56 lots of NaturaLyte ® Liquid Bicarbonate Concentrate, 6.4 liters has been classified as Class I, which is the U.S. Food and Drug Administration’s (FDA’s) most serious recall status. A Class I recall means that exposure to the recalled product can lead to serious injury or death.
Fresenius said that the voluntary recall was issued because the affected lots may develop more bacteria than allowed by the company’s internal specifications. The lots were produced in the company’s Montreal, Canada facility. According to the Fresenius press release, laboratory testing has confirmed the presence of Halomonas bacteria (species 1,2,3) which is often found in water with high salt content. Medical literature suggests that this type of bacterial contamination could lead to bacteremia or systemic infection. The filter used in the dialysis machine make this unlikely to occur, Fresenius said.
This is not the first time Fresenius has had trouble with its NaturaLyte dialysis product. The company has been sued by a number of people for hiding potentially fatal problems with NaturaLyte and GranuFlo. Both of these products contain acetate, which helps to neutralize the acid in the blood during dialysis. However, these two products contained more acetate than competing products. If doctors do not account for this, than a dosing error placed patients at risk for metabolic alkalosis; this is a risk factor for problems such as low blood pressure, cardiopulmonary arrest and even death. An internal memo dated November 4, 2011 discussed this issue, but the information was never made public intil prompted by the FDA.
A Class I recall was issued for GranuFlo and NaturaLyte powder acid concentrate in June 2012 because of the dosing issue. Since then, hundreds of lawsuits have been filed alleging that Fresenius Medical Care faield to adequately warn about cardiac arrest risks related to NaturaLyte and GranuFlo. Last March, many of these cases were centralized in the District of Massachusetts.