Recall Z-0327-2025 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
| Date | Nov 13, 2024 (initiated Oct 16, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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. - D |
| Quantity | 1100 units |
| Distribution | US Nationwide distribution and worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232467 | CleanCart A, CleanCart C, AK 98 Hemodialysis Machine Baxter Healthcare Corporation, Sep 14, 2023 |