FDAFDA · Food and drugs·Recall number Z-0197-2014
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Published November 20, 2013 · Recall initiated: June 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- Worldwide Distribution-USA including Puerto Rico and Canada.
- Lot
- Product Code: 35700BAX, 35700ABB Serial Numbers: All
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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