Medical device recalls Moderate risk

Baxter Healthcare Corporation recalls Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8…

Recall date
July 17, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2582-2024
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

Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and 3570009 (Spectrum IQ infusion pump)

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