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FDA classifies Avanos Medical’s Cortrak*2 EAS recall as Class I

Avanos Medical called off Cortrak* 2 EAS in response to the patient deaths and injuries caused by tube displacements.

The US Food and Drug Administration has classified Avanos Medical's Cortrak*2 enteral Access System (EAS), as a Class 1 recall.

The most serious of the three types is a Class I recall.

Avanos Medical Avanos Medical has recalled Cortrak*2 EAS following reports of deaths or injuries from nasogastric tube misplacements.

The device is intended to help health care workers place medical feeding tubes onto patients.

Avanos Mediacal Cortrak 2 However, improper placement of the nasogastric/nasoenteric tubs result in severe injuries or even death.

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

The recall communication from the company added that there have been more than 23 deaths in patients since 2015 due to the misplacement of the nasogastric feeding tubes when using the Cortrak* 2 EAS.

Avanos Medical will make the necessary changes to the labelling of the device in the wake of the recall. Avanos Mediacal Cortrak 2 This will include the updating of Cortrak*2 EAS's instructions as well as the intended use.

These revised guidelines direct users to check the placement of tubes in accordance with the protocol of the institution's prior use.

Avanos Medical is based in Alpharetta (Georgia) in the United States. https://www.indiegogo.com/individuals/31546091/ It specializes in manufacturing medical devices. Avanos Medical markets its well-known brands in over 90 countries.

https://list.ly/corbettrojas962 The company reached an agreement with OrthogenRx to acquire the company for $160 million in a transaction. Avanos Medical successfully closed the acquisition of OrthogenRx on 20 January.


My Website: https://www.indiegogo.com/individuals/31546091/
     
 
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