Device product
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Z-0327-2025
Product summary
- Event
- Event 95527
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1100 units
- Official record key
device-enforcement:Z-0327-2025
Official wording
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.
Code information: UDI/DI 07332414124519, All serials with runtime less than 500 hours
Distribution pattern: US Nationwide distribution and worldwide
Derived failure modes
-
Unknown
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.