The FDA issued a notice declaring a recall of some Fresenius Medical Care hemodialysis machines as Class I, the most serious kind.
Fresenius Medical Care recalled some of its 2008 Series hemodialysis machines that may cause exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) that leach from some peroxide-cured silicone tubing used as part of the hydraulics in the machine and dialysate lines.
Hemodialysis machines act as an artificial kidney, pumping blood from a person’s body to remove toxins and excess water. The use of affected machines in this case could cause serious adverse health consequences months to years after exposure. That includes endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes) and male infertility.
Fresenius Medical Care reports no deaths related to this recall. It recalled 207 devices distributed between Aug. 21, 2008, and June 6, 2022, after initiating the recall on Nov. 25, 2022. The company plans to update those affected machines that contain the chlorinated peroxide-cured silicone tubing. These machines set to be updated may not have been used or were in use for less than 36 days or 486 total hours.
The company issued an urgent medical device correction letter to affected customers on Sept 6, 2023. It instructed customers to contact Fresenius Medical Care if they have the machine that contains the tubing and falls under the update criteria. The company intends to update those machines to platinum-cured silicone tubing, free of charge.
If a customer purchased a new machine from the company after October 2022, they have no reason to take action. Fresenius Medical Care manufactured those machines with the updated platinum-cured silicone tubing.
Statement from Fresenius
Fresenius issued a statement clarifying that the voluntary recall does not involve the removal of devices from the marketplace. In early 2022, it reported to the FDA the finding of the NDL PCBAs in the tubing of some machines. It did not find any reports of known health risks or impact of PCBAs in medical literature.
After conducting investigations, the company determined that PCBAs in new dialysis machines rinse out after 486 hours of use.
“We worked closely with the FDA and have since resolved the issue. … We worked diligently to change to and gain FDA clearance for new platinum catalyst silicone tubing.”
That new clearance came in October 2022, hence why all new machines since use platinum catalyst silicone tubing.
“Fresenius Medical Care’s top priority is to always provide safe, high-quality, and life-sustaining acute and chronic dialysis therapy,” the statement said.