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Avanos Medical pulled Cortrak*2 EAS off service following reports about injuries and deaths due to tube missing.
The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak*2 Enteral Access System (EAS) as Class I recall.
Avanos Mediacal Cortrak 2 A Class 1 recall is the most serious among three classes.
Avanos Medical called off Cortrak*2, EAS, after deaths and injuries that resulted from the misplacement of nasogastric tubs.
Avanos Medical feeding tube The device was designed to help medical professionals who are trained to place medical feeding tubes inside patients. Avanos Mediacal Cortrak 2 It also provides live information about the tube's location in real-time. placement.
Cortrak 2 eternal access system However, improper placement of nasogastric or nasoenteric tubes can damage a patient's vocal cords, lungs or trachea, resulting in serious injuries or death.
The recall covers 629 devices that were sold in the US between February 1st, 2016 until 1 January 2022.
The company recall communication stated that 60 patients had been injured and 23 of them died as a result of the wrong placement of nasogastric tubes when using Cortrak* 2 EAS.
Avanos Medical is updating the labels on the device following the recall. https://biotech-insider.com/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/ This will include changing the instructions for Cortrak*2 EAS as well as its intended uses.
Users are also advised to ensure that the tubes are placed according to protocols of the institution before they utilize them.
Avanos Medical's headquarters is located in Alpharetta Georgia USA. https://www.simmonsandfletcher.com/blog/injuries-incorrect-feeding-tube-placement/ They specialize in manufacturing medical devices. The company has more than 90 markets to sell its renowned brands.
In December Avanos Medical entered into a $160 million deal to purchase OrthogenRx. Cortrak 2 eternal access system Avanos Medical completed the acquisition on January 20.
Homepage: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/
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