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Recall Observatory FDA recall evidence

Device product

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

Z-0327-2025

October 16, 2024

Class I

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 95527
Status
Ongoing
Classification
Class I
Quantity
1100 units
Official record key
device-enforcement:Z-0327-2025

Official wording

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.

Code information: UDI/DI 07332414124519, All serials with runtime less than 500 hours

Distribution pattern: US Nationwide distribution and worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.