It's Class I For Recall Of Smiths Medical Insulin Syringes, FDA Says
Certain models and lots of Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes were recalled on 16 June because they “may exhibit skewed odd number line graduation markings on their syringe barrels.”
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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.