Baxter: If Your Lips Turn Blue, Stop Using Our Device
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.
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For Second Time This Month, Medtronic Announces Class I FDA Recall Related To HeartWare System Component
Medtronic, Baxter and BD are all facing recalls, with Medtronic finding yet another issue with HeartWare HVAD systems. Separately, the FDA put a Baxter respiratory device recall into Class I, and BD announced a recall on intraosseous devices.
The US agency said the device maker initiated the recall in December because the pumps might not alarm for repeated occlusion events.
Baxter’s management justified the deal by emphasizing the potential cost synergies and shared commitment to digital health innovation.