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# Toxic Risk with Fresenius Hemodialysis Machines: FDA
- URL: https://www.fdaweb.com/toxic-risk-with-fresenius-hemodialysis-machines-fda/
- Published: 2022-05-06T12:00:00.000Z
- Updated: 2026-09-14T17:43:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151763

FDA is warning about the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) with the following Fresenius Medical Care hemodialysis machines (models 2008T, 2008K2, and 2008K). The 2008K2 and 2008K models are no longer manufactured but may still be in clinical use, the agency says.

The source of the toxic compounds is the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines, an [FDA alert ](https://www.fda.gov/medical-devices/letters-health-care-providers/potential-risk-exposure-toxic-compounds-when-using-certain-hemodialysis-machines-manufactured?ref=fdaweb.com)says. “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,” it says.

FDA says that so far it has not received any adverse event reports related to this matter. However, adverse effects of “NDL PCBs in animals have been reported in the literature, such as endocrine dysfunction, hepatic effects, neurobehavioral alterations, and male reproductive effects.”

The agency is working with Fresenius to further collect and evaluate data to determine the exposure risk and to develop strategies to mitigate the issue. “Preliminary data provided by the manufacturer to date suggest that the amount of NDL PCBAs and NDL PCBs might decrease over the first month during routine clinical use of the hemodialysis machine,” it says, adding that additional testing is needed.