“Non-dioxin-like polychlorinated biphenyl acid leaching was found in the peroxide-cross linked silicone tubing for these devices,” the agency said, and patients weighing less than 88 pounds could be exposed to dangerous levels of the acid.
Months and yearslong exposure can cause endocrine dysfunction, liver issues, neurobehavioral changes, skin problems and male infertility. No injuries or deaths have been reported.
Fresenius Medical told customers about the risk in February.
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