SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Reported: November 20, 2013 Initiated: June 10, 2013 #Z-0197-2014
Product Description
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Reason for Recall
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.
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 273,835 units
- Distribution
- Worldwide Distribution-USA including Puerto Rico and Canada.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.. Recalled by Baxter Healthcare Corp.. Units affected: 273,835 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2013. Severity: Moderate. Recall number: Z-0197-2014.
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