More than a year after the FDA sent a letter to healthcare providers warning them that the use of certain Fresenius Medical Care’s hemodialysis machines could expose patients to toxic compounds, the agency has branded a recall of some of those devices with its most serious Class I label.
The recall—which represents a product correction, rather than a removal of the machines from the market—began in late 2022, but it wasn’t until this month that the FDA handed down its classification, according to an agency update Tuesday.
Fresenius is recalling several versions of its 2008T dialysis devices that were sold between August 2008 and early June of last year, including more than 200 machines in the U.S.
The affected machines were equipped with peroxide-cured silicone tubing for hydraulics purposes. As the FDA described in its May 2022 letter to healthcare providers, non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) may leach from that tubing, and while the tubing doesn’t come into direct contact with a patient’s blood during the dialysis process, the released chemicals could potentially reach the blood if back-filtration through the dialyzer occurs.
According to the FDA, exposure to NDL PCBAs could possibly cause long-term health effects, including hormonal dysfunction, liver issues, neurobehavioral changes, skin conditions and male infertility. The agency is still in the process of evaluating “the potential risk of exposure to toxic compounds when using dialysis systems”—including those from manufacturers other than Fresenius—it said in another letter to healthcare providers in March of this year, but suggested that the benefits of dialysis machines currently still outweigh the possible risks and so should still be used.
The regulator noted in last year’s letter that it had yet to receive any reports of adverse events related to chemicals released by Fresenius’ devices, and it confirmed in this week’s recall notice that there have been no reports of patient deaths associated with the issue.
Fresenius has already taken steps to correct the issue: Since the end of October 2022, the company has swapped in FDA-cleared platinum-cured silicone tubing for the peroxide-cured option, so all dialysis machines sold after that point are excluded from the recall.
The company is now in the process of updating the tubing in certain recalled machines—a process that earned Fresenius the Class I tag.
The recall is specifically focusing on 2008T model dialysis machines that were distributed between the designated dates and either haven’t been used at all or have been used for less than 486 total hours, since, as the FDA noted, “Data provided by the manufacturer indicates that the amount of NDL PCBAs decreases over the first month during routine clinical use of the hemodialysis machine.”