Medical device recalls Moderate risk

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

Recall date
December 20, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1010-2025
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
US Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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