SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
Reported: April 30, 2014 Initiated: February 7, 2014 #Z-1484-2014
Product Description
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
Reason for Recall
Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.
Details
- Recalling Firm
- Baxter Healthcare Corp.
- Units Affected
- 277,096 units (revised)
- Distribution
- Worldwide Distribution - USA Nationwide including PR and the country of Canada.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.. Recalled by Baxter Healthcare Corp.. Units affected: 277,096 units (revised).
Why was this product recalled? ▼
Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 30, 2014. Severity: Critical. Recall number: Z-1484-2014.
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