CLASS I ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report

Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System recalled

Baxter Healthcare is recalling Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, distributed nationwide in the US. The recall was initiated on 16 Oct 2024 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI/DI 07332414124519, All serials with runtime less than 500 hours

Quantity recalled1100 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0327-2025
FDA event ID: 95527
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class I
Status: Ongoing
Recall initiated: 16 Oct 2024
FDA classified: 13 Nov 2024
Reported: 20 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Oct 2024	Recall initiated by company
13 Nov 2024	Classified by FDA	+28 days
20 Nov 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution and worldwide

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide distribution and worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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