Recall Z-0204-2026— Baxter Healthcare Corporation

Name: FDA recall Z-0204-2026
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. FDA's recall record names no specific 510(k) clearance for this event. Product: CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519. 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

Product description

CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519

Reason for recall

IV sets may leak.

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