Baxter Healthcare Corporation recalls Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spe…

Recall date

July 17, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2581-2024

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

US, Nationwide

Why it was recalled

The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.

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 Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump