Warning Letter Close-Outs – December 2021
The US FDA released only one device-related close-out letter last month.
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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.