FDA-Device2024-11-20Class I
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Baxter Healthcare Corporation
Hazard
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.
Sold states
US Nationwide distribution and worldwide
Affected count
1100 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0327-2025Don't want to check this manually?
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