Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607
This recall is currently active, issued November 13, 2024. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- October 16, 2024
- Posted
- November 13, 2024
- Recall Number
- Z-0327-2025
- Quantity
- 1100 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution and worldwide
Lot / Code Info
UDI/DI 07332414124519, All serials with runtime less than 500 hours
Root Cause
Nonconforming Material/Component
Action Taken
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