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Avanos Medical has recalled Cortrak*2 EAS because of reports of injuries and deaths caused by tube malfunctions.
Cortrak 2 eternal access system The US Food and Drug Administration (FDA), has designated the recall by Avanos Medical of Cortrak*2 Ental Access System, (EAS) as a class I recall.
A Class I can remember is considered to be the most serious out of the three classes.
Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries or deaths due to misplacements of the nasogastric tube.
This device can be used to aid trained healthcare professionals to insert medical feeding tubes in patients. It also gives real-time details about the placement of tubes.
But, incorrect placement of nasogastric/nasoenteric tubs can result in severe injuries or even death.
The company has recall 629 devicesthat were made available in the US from April 1st, 2016 to 1 January 2022.
feeding tube placement The company also noted in a recall communication that there had been 60 injuries and 23 patients killed since 2015 because of the feed tubes that were not properly placed when using the Cortrak* 2 EAS.
https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges Avanos Medical, following the recall, will update the device's labelling. This includes updating the instructions on how to use the device as and the intended uses for Cortrak*2 EAS.
The revised guidelines advise users to confirm that the tube is set up according to the protocol of the institution before to its use.
https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/ Avanos Medical's headquarters is located in Alpharetta Georgia the United States of America. They focus on the manufacturing of medical devices. The company sells its recognized brands across over 90 countries.
The company signed a $160m contract in December last year to purchase OrthogenRx. Avanos Medical Avanos Medical successfully closed the acquisition of OrthogenRx on the 20th of January.
Here's my website: https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/
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