Early Alert: Intravascular Administration Set Issue from Baxter

Published: 07/20/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Ambulatory Surgical Centers,
  • Rural Emergency Hospitals,
  • Urgent Care,
  • Dialysis Facilities,
  • Critical Access Hospitals,
  • Home Health,
  • Hospitals,
  • Long Term Care,
  • Ambulatory Care,
  • Office-Based Surgery,
  • Inpatient Rehabilitation Facility,
  • Pharmacy,
  • Hospice,
  • Rural Health Clinics

The FDA is aware that Baxter has issued a letter to affected customers recommending certain Duo-Vent solution sets be removed from where they are used or sold. 

Baxter stated that certain lots of Duo-Vent solution sets may have air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.

Affected Devices:

Product Code

Product Description

Lot Numbers

UDI-DI

Sign Up for Free Trial