Baxter Healthcare Corporation recalls Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is…

Recall date

October 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0327-2025

FDA classification

Class I

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

US Nationwide distribution and worldwide

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.