Medical device recalls Moderate risk

Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2

Recall date
November 19, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0776-2025
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
US Nationwide distribution in the states of AL, IN.

Why it was recalled

Devices were identified as released after repair without full testing being performed, which includes flow testing.

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 SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2

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