Recall Of Device For Critically Ill Newborns High-Risk Class I, FDA Says
The GENOSYL DS Nitric Oxide Delivery System was recalled by Vero Biotech because the device’s software could deliver an incorrect dosage of nitric oxide, a drug used on newborns experiencing respiratory failure.
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The recalled vents are designed to provide high-flow therapy to patients, but problems can crop up “if the system pressure reaches the default maximum limit,” the US agency says. The recall is more bad news for Philips, which recently initiated a separate class I recall of certain breathing and ventilator devices.
The US agency on 3 August said the webform should be used by manufacturers to report shortages of products deemed critical to fighting the ongoing COVID-19 pandemic.
Alere Medical and its now-defunct subsidiary Arriva Medical will pay the US government $160m to settle allegations that they violated the False Claims Act. It’s the second settlement that Alere has entered into with the Department of Justice in recent weeks.