Home / Recalls / Baxter Healthcare Corporation / Z-0327-2025

Z-0327-2025 Class I Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
November 20, 2024
Initiation Date
October 16, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1100 units

Product Description

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

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 Pattern

US Nationwide distribution and worldwide

Code Information

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

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  • D-0296-2026 Class II — Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxte (December 22, 2025)
  • Z-1121-2026 Class II — SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 (November 28, 2025)
  • Z-0847-2026 Class II — Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product r (October 28, 2025)
  • Z-0233-2026 Class II — Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Pl (September 17, 2025)
  • Z-0203-2026 Class II — CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and C (August 29, 2025)
  • Z-0195-2026 Class II — CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CL (August 29, 2025)
  • Z-0190-2026 Class II — CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drop (August 29, 2025)