Recall Z-0195-2026— Baxter Healthcare Corporation

Name: FDA recall Z-0195-2026
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: K153158. Product: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571. 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

K153158 — Solution Administration Sets with 0.2 Micron FilterBaxter Healthcare Corporation·cleared 2015-12-28

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, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571

Reason for recall

IV sets may leak.

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