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FDA has identified Avanos Medical's Cortrak*2 EAS recall as Class I

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

feeding tube placement The US Food and Drug Administration has acknowledged the Cortrak*2 of Avanos Medical's Enal Access System Recall (EAS) in a Class I recall.

A Class I Recall is the most serious type of the three classes.

Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries or deaths caused by misplacements of nasogastric tubes.

This device can be used to assist trained health professionals with the placement of medical feeding tubes in patients. Avanos Medical It also provides in real-time information regarding tube placement.

However, the incorrect placement of the nasogastric or nasoenteric tubes could result in severe injuries or even death.

The company has recall 629 units, which were made available in the US from 1 April 2016 until 1 January 2022.

The notice of recall issued by the company stated that there had been 60 injuries and 23 deaths in patients since 2015 due to misplacement of nasogastric feeding tubes while using the Cortrak* 2 EAS.

Avanos Medical will make the necessary changes to the labelling of the device in the wake of the recall. This includes an update of the instructions regarding the use and intended usage of Cortrak* 2 EAS.

Users are also directed to verify that tubes have been put in the correct manner according to the guidelines of the institution before they use.

Avanos Medical feeding tube Avanos Medical's headquarters are located in Alpharetta Georgia USA. Avanos Medical feeding tube They are a specialist in the production of medical equipment. Avanos Medical's well-known brands are sold in over 90 countries.

Last December, the company entered into a $160 million deal to acquire OrthogenRx. Avanos Medical closed on the acquisition in January.

feeding tube placement
Here's my website: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/
     
 
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