Baxter AK 98 Dialysis Machine (Baxter) – Chemical Risk (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
UDI/DI 07332414124519, All serials with runtime less than 500 hours
Products Sold
UDI/DI 07332414124519, All serials with runtime less than 500 hours
Baxter Healthcare Corporation is recalling Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607 due to Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated bipheny. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Baxter is aware of several 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 hemodialysis devices.
Recommended Action
Per FDA guidance
Baxter issued an IMPORTANT MEDICAL DEVICE CORRECTION notice to its consignees on 10/16/2024 via USPS, first class mail. The notice explained the issue, potential safety risk, and requested the following actions be taken: Actions to be Taken by Customers Until Baxter has completed the transition to the newly manufactured platinum-cured silicone tubing components in the AK 98 machines, the firm is recommending the following actions: " If you have new AK 98 machines with a runtime of less than 500 hours, consider using alternative machines including AK 98 machines with a runtime greater than 500 hours, if any are available, as PCB and PCBA levels decrease over time of machine use. - If only AK 98 machines with a runtime of less than 500 hours are available, continue to use them to ensure your patients have access to dialysis treatment. - Do not stop dialysis treatment to patients who need it. - Please contact Baxter Renal Customer Care to provide the serial numbers of your AK 98 machines with a runtime of less than 500 hours to determine a correction plan for your site. Baxter Renal Customer Care can be reached at 800-525-2623, option 2, option 2, between the hours of 7:00 am and 5:00 pm Central Time, Monday through Friday. - Until the transition to platinum-cured silicone tubing components has been completed or an alternative solution is identified and implemented to reduce the possible presence of PCB and PCBA below the FDA recommended limits, Baxter has imposed a shipment hold on new AK 98 machines, to the extent consistent with the treatment needs of the dialysis population in our customers care. If you identify a medical need that requires you to order a new AK 98 machine with the peroxide-cured silicone tubing, please contact your Baxter Renal Sales Representative for further instructions on placing the order. - If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026