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
• Code Information: UDI/DI 07332414124519, All serials with runtime less than 500 hours
• 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 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
• Quantity in Commerce: 1100 units
• Distribution: US Nationwide distribution.
• 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