Recall Z-0327-2025— Baxter Healthcare Corporation

Name: FDA recall Z-0327-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-16

Class I · Ongoing

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-10-16. It names one FDA 510(k) clearance: K232467. 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
Status: Ongoing
Initiated: 2024-10-16
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K232467 — CleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation·cleared 2023-09-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.