Baxter Healthcare Corporation: Device Recall

Recall Details

Recall Number

Z-0327-2025

Classification

Class I

Product Type

Device

Recalling Firm

Baxter Healthcare Corporation

Status

Ongoing

Date Initiated

10/16/2024

Location

Deerfield, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1100 units

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 Description

Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607

Distribution Pattern

US Nationwide distribution and worldwide

Other Recalls by Baxter Healthcare Corporation

• Class II: Risk 12/22/2025
  Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
• Class II: Risk 11/28/2025
  Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
• Class II: Risk 10/28/2025
  Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
• Class II: Risk 09/17/2025
  Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
• Class II: Risk 08/29/2025
  IV sets may leak.

View all recalls by Baxter Healthcare Corporation →