Fresenius Medical Care Recalls Hemodialysis Machines Due to Potential Exposure to Toxic Compounds

Fresenius Medical Care has announced it is voluntarily recalling certain units of its 2008 Series Hemodialysis Machines following concerns of potential exposure to non-dioxin-like polychlorinated biphenyl acids (PCBAs). The U.S. Food and Drug Administration (FDA) has categorized this recall as Class I, the most serious type of recall, as the use of these devices may result in serious injuries or even death. However, the recall is a product correction, not a product removal.

Fresenius Medical Care’s 2008 Series Hemodialysis Machines are designed to perform hemodialysis treatment, where they help pump blood from a patient’s body to remove toxins and excess water. Hemodialysis is a life-sustaining therapy for individuals with impaired kidney function and Fresenius is a market leader in selling dialysis equipment.

The recall was initiated by Fresenius Medical Care due to concerns over the potential exposure of patients to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs). These harmful compounds have been found to leach from certain peroxide-cured silicone tubing used in the hydraulics of the machines and dialysate lines. While data from the manufacturer indicates that the levels of NDL PCBAs tend to decrease over the initial month of clinical use, the exposure to these toxic substances can have serious health implications. It is important to note that the health consequences of exposure to these compounds may not be immediately apparent. The potential adverse effects could emerge months to years after exposure and may include endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (such as acne and rashes), and male infertility. While there have been reports of adverse health effects, there have been no reported deaths associated with the use of these affected machines.

The affected machines in question were manufactured between August 21, 2008, and June 6, 2022. The recall applies to machines that contain chlorinated peroxide-cured silicone tubing and have either not been used or have been in use for less than 36 days. Fresenius Medical Care initiated an Urgent Medical Device Correction letter on September 6, 2023, specifically for affected customers. The letter instructs customers with hemodialysis machines containing chlorinated peroxide-cured silicone tubing and these machines have not been used or have been in use for less than 36 days to contact Fresenius Medical Care. The company is offering an update for these machines to incorporate platinum-cured silicone tubing, and this update will be provided free of charge.