Baxter has issued a correction for its AK 98 haemodialysis machines, with the US Food and Drug Administration (FDA) classifying the recall as Class I.
Class I indicates the agency’s most serious designation for a recall, meaning continued use of the products, without actions being taken, could cause serious injury or death. Although it is classified as type I recall, it does not involve removing devices only the correction of AK 98 haemodialysis machines with product code – 955607.
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Baxter noted that the correction was based on “recent recalls by other manufacturers” related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and haemodialysis devices.
In April, Fresenius Medical Care issued a correction of its Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter. The significant recall affected more than two million devices, which were distributed between 5 March 2003 and 25 January 2024. During the same period, Outset Medical also issued a correction for its Tablo hemodialysis device.
Both the recalls were tagged as Class I by the FDA and followed the agency’s letter to healthcare providers. The letter stated that the agency is evaluating the “potential risk of exposure to toxic compounds when using dialysis systems.” In addition, the letter said that “the FDA is aware of other haemodialysis and peritoneal dialysis systems that have parts made of chlorinated peroxide cured silicone but we do not know at this time whether there is any risk of exposure to NDL PCBAs or NDL PCBs”.
The FDA stated that NDL PCBAs and NDL PCBs are present in the silicone tubing of dialysis systems. Noting that more testing and analysis are needed to determine if NDL PCBAs or NDL PCBs are present in the systems and if so, the amount and extent of exposure to patients of these toxic compounds.
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By GlobalDataBaxter noted in the correction notice that the company is “in the process of evaluating whether the source of PCBAs and/or NDL PCBs in those recalls (the silicone tubing manufacturing process using a chlorinated peroxide initiator) is present in AK 98 dialysis machines.” Adding that the company is also transitioning “certain components” in the machines from peroxide-cured silicone tubing to platinum-cured silicone tubing, as “NDL PCBAs and NDL PCBs are not detected in medical devices with this modified version of silicone tubing”.
There were no reported injuries or deaths, but adverse health effects from months or years of exposure include endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), male infertility, and death.
The Baxter AK 98 dialysis machine is intended to be used for intermittent haemodialysis and/or isolated ultrafiltration treatments for people with chronic or acute kidney failure or fluid overload. Baxter asked consumers, if possible, to not use the newer AK98 machines with less than 500 hours of runtime, but instead use alternative haemodialysis machines, including AK 98 machines with 500-plus runtime hours.
In June, the FDA tagged a recall of Baxter’s respiratory devices, Life2000 ventilation system, as Class I. The recall was issued following reports that the systems were failing to charge due to damage to the battery charger dongle. This issue was also causing devices to have “intermittent changing behaviour”.
