Recall Z-2594-2025— Baxter Healthcare Corporation

Name: FDA recall Z-2594-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-08

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-08-08. It names one FDA 510(k) clearance: K203609. Product: Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set. Reason: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-08-08
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

Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set

Reason for recall

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.

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