Recall Z-1010-2025— Baxter Healthcare Corporation

Name: FDA recall Z-1010-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-20

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-12-20. It names one FDA 510(k) clearance: K180739. Product: Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538. Reason: Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-12-20
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K180739 — Clearlink System Solution SetBaxter Healthcare Corporation·cleared 2019-05-28

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

Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538

Reason for recall

Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.

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