Recall Z-2766-2026— Baxter Healthcare Corporation

Name: FDA recall Z-2766-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-30

Class I · Ongoing

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2026-06-30. It names one FDA 510(k) clearance: K243529. Product: Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets. Reason: Baxter received customer reports of 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
Status: Ongoing
Initiated: 2026-06-30
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K243529 — Solution Administration SetsBaxter Healthcare Corporation·cleared 2025-03-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets

Reason for recall

Baxter received customer reports of 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.