Z-0327-2025Class I

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

Name: Z-0327-2025 Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the...
Creator: Baxter Healthcare Corporation
Published: 2024-10-16
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2024-10-16 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive on 2024-10-16. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0327-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-10-16
Posted: 2024-11-13
Recalling firm: Baxter Healthcare Corporation
Product: Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Baxter sent an IMPORTANT MEDICAL DEVICE CORRECTION notice to its consignees on 10/16/2024 via USPS. Until Baxter has transitioned to newly manufactured platinum-cured silicone tubing components in AK 98 machines, the firm recommends these actions: - If you have new AK 98 machines with a runtime less than 500 hours, consider using other available machines including AK 98 machines with a runtime greater than 500 hours, as PCB and PCBA levels decrease over time of use. - If no alternative is available, continue to use the AK 98 to ensure your patients have access to dialysis treatment. - Do not stop dialysis treatment to patients who need it. - Call Baxter Renal Customer Care at 800-525-2623, option 2, option 2, between 7:00 am and 5:00 pm CT, Monday thru Friday to provide the serial numbers of your AK 98 machines with a runtime less than 500 hours to determine a correction plan for your site. - Until the solution is implemented to reduce the possible presence of PCB and PCBA below the FDA recommended limits, Baxter is holding shipment of new AK 98 machines, allowing for the treatment needs of the dialysis population in our customers care. If you have a medical need for a new AK 98 machine with the peroxide-cured silicone tubing, contact your Baxter Renal Sales Representative for instructions on placing the order. - Please forward a copy of this communication to other facilities or departments that have this product. ***Updated 12/3/25*** On 12/3/2025, Vantive sent a follow-up Important Medical Device Correction letter. This letter contained an update to health hazard based on Vantive's toxicological risk assessment. The issue is unlikely to pose a risk for patients with a body weight greater than 25kg, irrespective of the run-time of the machine. The firm has determined that no corrections are needed for devices currently with customers, and patients may continue therapy with the current configuration of AK 98.
Quantity in commerce: 1100 units
Distribution: US Nationwide distribution and worldwide
Product codes and lots: UDI/DI 07332414124519, All serials with runtime less than 500 hours

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0327-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0327-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-13

Product code KDI

K232467Class IICleanCart A, CleanCart C, AK 98 Hemodialysis MachineBaxter Healthcare Corporation / cleared 2023-09-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)