FDAClass INovember 20, 2024

Baxter AK 98 Dialysis Machine recall

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

Why was Baxter AK 98 Dialysis Machine recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Recalling firm
Baxter Healthcare Corporation
Quantity
1100 units
Distribution
US Nationwide distribution and worldwide
Recall date
November 20, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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