The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used in Fresenius Medical Care (NYSE: FMS) hemodialysis machines.
The investigation concerns three models of Fresenius hemodialysis machines: the 2008T, 2008K2, and 2008K.
The chemicals — non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) — are in the silicone tubing used in the dialysate lines and the machine’s hydraulics.
“Although this silicone tubing does not directly contact the blood, there is the potential for back filtering through the dialyzer into the patient’s blood circulation during treatment,” the FDA said in a May 6 letter to health care providers.