Fresenius Medical’s Changes to 2008T Hemodialysis Machines Cleared
The FDA has cleared changes to Fresenius Medical’s 2008T hemodialysis machines including modified silicone tubing in the hydraulics of the machine.
The changes are intended to address the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids and NDL polychlorinated biphenyls.
Although the silicone tubing that was considered the source of the problem does not directly contact the blood, there is potential for back filtering through the dialyzer into the patient’s blood circulation during treatment, the FDA said.
The company said it will begin shipping the modified hemodialysis machines immediately.