FDA – October 28, 2022 Update
On October 27 2022, the FDA cleared changes to Fresenius Medical’s 2008T hemodialysis machines that include use of modified silicone tubing in the hydraulics of the machine, specifically platinum catalyst silicone tubing. Based on information provided by the manufacturer, non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) were not detected in machines with the modified silicone tubing. 2008T hemodialysis machines with modified silicone tubing will be shipped after October 27 2022, and should be used according to their instructions for use. The recommendations in the May 6, 2022, letter below do not apply to these machines with the modified silicone tubing.
