FDAFDA · Food and drugs·Recall number Z-2581-2024
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
Published August 28, 2024 · Recall initiated: July 17, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US, Nationwide
- Lot
- Pump GTIN 00085412498683; All serial numbers with radio software versions 22D28, 22D29, and 22D30
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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