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FDA confirms the Avanos Medical Cortrak* 2 EAS recall as Class I

Avanos Medical pulled Cortrak*2 EAS from service after receiving reports about injuries and deaths due to tube misplacements.

The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak*2 Enteral Access System (EAS) as a Class I recall.

The most serious of the three kinds is the Class I recall.

Avanos Medical pulled Cortrak* 2 EAS out of service due to patient deaths and injuries due to nasogastric tubes misplacements.

The device is able to assist health professionals with the placement of medical feeding tubes into patients. Avanos Mediacal Cortrak 2 It also provides in real-time information regarding tube placement.

But, incorrect placement of the nasogastric/nasoenteric tubs cause serious injuries or even death.

The company has now recalled 629 devices from the US which were distributed between April 1st, 2016 and 1 January 2022.

Avanos Medical feeding tube http://www.drugoffice.gov.hk/gb/unigb/controlc.com/dbd81783 According to the recall notice the company has stated that as of 2015, there had been more than 60 injuries and 23 deaths as a result of the incorrect placement or misuse of the nasogastric feeding tube while making use of the Cortrak* 2 EAS.

Avanos Medical will make the necessary changes to the labelling of the device following the recall. This will include updating the instructions on use and intended use of Cortrak* 2 EAS.

These revised guidelines direct users to ensure that the tube is placed according to the institution's protocols prior use.

https://www.transtats.bts.gov/exit.asp?url=https://pastelink.net/q5emdw4v Avanos Medical is based in Alpharetta (Georgia) in the United States. It specializes in the manufacturing of medical devices. It sells its brands across more than 90 countries.

https://setiweb.ssl.berkeley.edu/beta/show_user.php?userid=10554826 Last December, the company signed an agreement to acquire OrthogenRx in an agreement worth $160 million. Avanos Medical closed the acquisition on January 20th.


Read More: http://sc.sie.gov.hk/TuniS/www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
     
 
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