Warning Letter Close-Outs – February 2022
The US Food and Drug Administration issued two close-out letters in February, with missives going to Invisi Smart Technologies and Indus Medicare.
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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.
US regulators plan to hold a public meeting later this year to address concerns the devices are less accurate for people with darker skin tones.
Some defective devices with potential obstructions were mistakenly distributed to clients instead of being destroyed.