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鈥檚 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 鈥� 955607.
Baxter noted that the correction was based on 鈥渞ecent 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 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 for its Tablo hemodialysis device.
Both the recalls were tagged as Class I by the FDA and followed the agency鈥檚 letter to healthcare providers. The letter stated that the agency is evaluating the 鈥減otential risk of exposure to toxic compounds when using dialysis systems.鈥� In addition, the letter said that 鈥渢he 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鈥�.
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 鈥渋n 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 鈥渃ertain components鈥� in the machines from peroxide-cured silicone tubing to platinum-cured silicone tubing, as 鈥淣DL PCBAs and NDL PCBs are not detected in medical devices with this modified version of silicone tubing鈥�.
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鈥檚 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 鈥渋ntermittent changing behaviour鈥�.
