Tag: Infusion system

FDA announces class 1 recalls for premixed embolic, infusion pump software

Editor's Note The US Food and Drug Administration has classified recalls of Boston Scientific’s Obsidio Conformable Embolic and Fresenius Kabi USA’s Ivenix Infusion System Large Volume Pump (LVP) software as class 1, the most serious category and an indicator of risk of serious injury or death. No injuries or deaths…

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By: Matt Danford
April 18, 2024
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FDA: Class I recall of certain ICU Medical infusion system batteries

Editor's Note The Food and Drug Administration (FDA), on May 22, identified the recall by ICU Medical of replacement batteries for its Plum 360, Plum A+, and Plum A+3 infusions systems as Class I, the most serious. The recall was initiated because a manufacturing defect substantially diminished how long the…

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By: Judy Mathias
May 23, 2023
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