Class 1 Device Recall AK 98 Dialysis Machine

• Date Initiated by Firm: October 16, 2024
• Date Posted: November 13, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0327-2025
• Recall Event ID: 95527
• 510(K)Number: K232467
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
• Code Information: UDI/DI 07332414124519, All serials with runtime less than 500 hours
• FEI Number: 1417572
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Baxter sent an IMPORTANT MEDICAL DEVICE CORRECTION notice to its consignees on 10/16/2024 via USPS. Until Baxter has transitioned to newly manufactured platinum-cured silicone tubing components in AK 98 machines, the firm recommends these actions: - If you have new AK 98 machines with a runtime less than 500 hours, consider using other available machines including AK 98 machines with a runtime greater than 500 hours, as PCB and PCBA levels decrease over time of use. - If no alternative is available, continue to use the AK 98 to ensure your patients have access to dialysis treatment. - Do not stop dialysis treatment to patients who need it. - Call Baxter Renal Customer Care at 800-525-2623, option 2, option 2, between 7:00 am and 5:00 pm CT, Monday thru Friday to provide the serial numbers of your AK 98 machines with a runtime less than 500 hours to determine a correction plan for your site. - Until the solution is implemented to reduce the possible presence of PCB and PCBA below the FDA recommended limits, Baxter is holding shipment of new AK 98 machines, allowing for the treatment needs of the dialysis population in our customers care. If you have a medical need for a new AK 98 machine with the peroxide-cured silicone tubing, contact your Baxter Renal Sales Representative for instructions on placing the order. - Please forward a copy of this communication to other facilities or departments that have this product. ***Updated 12/3/25*** On 12/3/2025, Vantive sent a follow-up Important Medical Device Correction letter. This letter contained an update to health hazard based on Vantive's toxicological risk assessment. The issue is unlikely to pose a risk for patients with a body weight greater than 25kg, irrespective of the run-time of the machine. The firm has determined that no corrections are needed for devices currently with customers, and patients may continue therapy with the current configuration of AK 98.
• Quantity in Commerce: 1100 units
• Distribution: US Nationwide distribution and worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KDI