Baxter’s Recall Of Spectrum Infusion Pumps Given Class I Label By FDA
The US agency said the device maker initiated the recall in December because the pumps might not alarm for repeated occlusion events.
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The US FDA has granted Baxter International 510(k) clearance for its new Novum IQ syringe infusion pump with safety hardware. The approval opens a new market opportunity for the company.
Baxter Healthcare says there’s a risk of decreased oxygen levels or lung over-expansion when using its Volara System “in line with a ventilator.” The firm launched a recall of the device on 1 June.
The urgent safety communication says the company has been notified about 51 serious injuries and three deaths related to issues with the pumps’ upstream occlusion alarms.