FDA Device recall Z-0327-2025
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607
- FDA Device
- Class I
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class I recall of Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607 by Baxter Healthcare, citing 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 polychl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0327-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-10-16 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
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.
Identifiers
| code_info | UDI/DI 07332414124519, All serials with runtime less than 500 hours |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0327-2025%22
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