Recall Z-0193-2026— Baxter Healthcare Corporation

Name: FDA recall Z-0193-2026
Creator: U.S. Food and Drug Administration
Published: 2025-08-29

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-08-29. It names one FDA 510(k) clearance: K203609. Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537. Reason: IV sets may leak..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-08-29
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K203609 — Intravascular Administration SetsBaxter Healthcare Corporation·cleared 2021-09-30

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

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537

Reason for recall

IV sets may leak.

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