Just under two months ago, Baxter International issued an urgent correction for all of their AK 98 Hemodialysis Machines with less than 500 hours of runtime due to concerns about exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs). According to the FDA, the announcement followed on the heels of similar recalls issued by other healthcare companies.
Healthcare providers at dialysis centers or hospitals use the AK 98 Hemodialysis Machine (UDI 07332414124519/955607) to filter the blood of patients with kidney disease or complications related to fluid overload. The machine should not be used with infants and very small children, as it is only appropriate for patients weighing at least 55 pounds.
Baxter issued an urgent Medical Device Correction letter pertaining to the AK 98 Hemodialysis Machine on October 16, 2024. The letter was prompted by recalls initiated by Fresenius and Outset Medical after reports of the possible risks associated with exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) released by similar products. Research suggests that these exposures may result from peroxide-cured silicone tubing. Baxter plans to examine to source of the tubing for their AK 98 Hemodialysis Machines and, if appropriate, replace any peroxide-cured tubing with platinum-cured silicone tubing.
In the letter, Baxter informs customers of the potential risks associated with the recalled device and advises dialysis providers to use an AK 98 Hemodialysis Machine with more than 500 hours of run time when possible. Alternately, providers can use a different, comparable device. Providers should continue use of the AK 98 Hemodialysis Machine with fewer than 500 hours of run time if they do not have access to an alternate device. Patients should not be forced to skip dialysis treatment as a result of the recall. Furthermore, Baxter asks customers to contact them at 800-525-2623 (option 2, option 2) for details regarding a correction plan for all AK 98 Hemodialysis Machines with fewer than 500 hours of run time. Finally, the company asks users to visit Baxter’s website to acknowledge receipt of the correction letter.
No injuries or fatalities have been reported thus far as a result of exposure to NDLs, PCBAs, and PCBs from the recalled product. The FDA urges users to comply with the recall and correction process, however, as continued use of the AK 98 Hemodialysis Machine without correction could cause delayed health complications, such as “endocrine dysfunction, liver issues, neurobehavioral changes, skin problems (acne, rashes), male infertility, and death.”
Anyone with questions or concerns about the correction can contact Baxter Renal Customer Care at 800-525-2623 (Option 2, Option 2). They are available Monday through Friday from 7:00 am to 5:00 pm, CST.
Patients and health care providers can report any new adverse health events related to use of Baxter’s AK 98 Hemodialysis Machines through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to use of Baxter’s AK 98 Hemodialysis Machines, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to customers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.