Home / Recalls / Baxter Healthcare Corporation / Z-1653-2022

Z-1653-2022 Class I Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
September 21, 2022
Initiation Date
August 9, 2022
Termination Date
August 9, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
511,728 units

Product Description

Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.

Reason for Recall

Firm noted an increase in customer reports of leaks.

Distribution Pattern

US Nationwide Distribution

Code Information

UDI/DI 00085412656649, All lots within expiry

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-1637-2026 Class I — Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. (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-0193-2026 Class II — CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Acti (August 29, 2025)
  • Z-0190-2026 Class II — CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drop (August 29, 2025)
  • Z-0202-2026 Class II — CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Acti (August 29, 2025)