Home / Recalls / Baxter Healthcare Corporation / Z-2095-2025

Z-2095-2025 Class I Ongoing

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
July 23, 2025
Initiation Date
June 20, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14 units

Product Description

Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

Reason for Recall

Certain Spectrum infusion pumps may have an incorrect version of software.

Distribution Pattern

US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.

Code Information

UDI-DI: 00085412091570; Serial Numbers: 765100 , 772744 , 789742 , 841197 , 867753 , 920606 , 1024015 770164 788724 , 793079 , 842498 , 918342 , 962810 , 1027523

Other recalls by Baxter Healthcare Corporation

  • Z-1573-2026 Class II — Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS (February 18, 2026)
  • Z-1368-2026 Class II — Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570 (January 13, 2026)
  • 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-0202-2026 Class II — CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Acti (August 29, 2025)
  • Z-0203-2026 Class II — CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and C (August 29, 2025)
  • Z-0197-2026 Class II — CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLE (August 29, 2025)
  • Z-0204-2026 Class II — CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H85 (August 29, 2025)