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Baxter’s Recall Of Spectrum Infusion Pumps Given Class I Label By FDA

 
• By Shawn M. Schmitt

The US agency said the device maker initiated the recall in December because the pumps might not alarm for repeated occlusion events.

Baxter building in Mississauga, Ontario.
• Source: Shutterstock

The US Food and Drug Administration on 11 March labeled a recall of Baxter Healthcare’s Sigma Spectrum infusion pumps as high-risk class I.

The agency said the company initiated the recall on 29 December because its Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ...

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