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FDA (Device enforcement)Recalled 2024-10-16class i

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

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.

Details from the source

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 Quantity: 1100 units Lot/code info: UDI/DI 07332414124519, All serials with runtime less than 500 hours

UPC codes

07332414124519

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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