Recall Z-0197-2026— Baxter Healthcare Corporation

Name: FDA recall Z-0197-2026
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: K112893. Product: CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610. 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

K112893 — CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETSBaxter Healthcare Corporation·cleared 2011-10-18

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 EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610

Reason for recall

IV sets may leak.

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