Class I
Medical Device Recall: Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Baxter Healthcare Corporation · October 16, 2024
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.
Distribution
US Nationwide distribution and worldwide
States Affected
NATIONWIDE
Quantity Affected
1100 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0327-2025
Status: ongoing
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