Tuesday, December 1, 2020

Baxter recalls SIGMA Spectrum Infusion Pump System

Learn more about Baxter Healthcare's recall of their Baxter SIGMA Spectrum Infusion Pump System

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US Food and Drug Administration

Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues

Baxter Healthcare is recalling the Baxter Healthcare Sigma Spectrum Infusion Pumps with Master Drug Library (V6, V8) and the Baxter Spectrum IQ Infusion Systems with Dose IQ Safety Software (V9) because improper cleaning of the devices may lead to residue build-up or corrosion on the device. If the device is running only on battery power, this may lead to an unplanned shutdown without alarming or alerting the user. This may cause an infusion delay or an interruption in treatment. Use of the affected product may cause serious adverse events, including death.

The FDA has identified this as a Class I recall, the most serious type of recall.

Read the Recall Notice


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