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FDA announces the Cortrak*2 of Avanos Medical's EAS Recall Class I

Avanos Medical called off Cortrak* 2 EAS as a result of patient injury and deaths caused by tube misplacements.

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

Avanos Medical A Class I recall is a reference to the most severe of the three classes.

Avanos Medical called off Cortrak*2, EAS, following injuries and deaths resulting from the misplacement of nasogastric tubs.

The device was designed to help trained health care personnel place medical tube feedings in patients and offer the most current information about tube placement.

However, the wrong positioning of nasogastric or nasal tubes could cause damage to a patient's vocal cords and trachea or lungs, resulting in serious injury or even death.

http://pandora.nla.gov.au/external.html?link=https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ The recall affects 629 devices that were available in the US between February 1st, 2016 until 1 January 2022.

The company also stated in a recall announcement that there were more than 23 patients and 60 injuries who died since 2015 due to the incorrect placement of nasogastric feed tubes in the Cortrak* 2 EAS.

Avanos Medical, following the recall, will be updating the labeling of the device. This includes updating the instructions for use as well as intended uses of Cortrak*2 EAS.

https://classificamp.com.br/index.php/author/avanos-mediacal-cortrak-2ggli271/ Avanos Medical These revised guidelines direct users to verify tube placement according to the institution's protocols prior use.

Headquartered in Alpharetta, Georgia, US, Avanos Medical focuses on the production of medical devices that are clinically proven. Avanos Medical Avanos Medical The brand's name is accessible in more than 90 countries.

In December of last year, the company signed an agreement to acquire OrthogenRx with an agreement worth $160 million. Avanos Medical successfully closed the acquisition of OrthogenRx on the 20th of January.

feeding tube placement
Read More: https://www.supratraderonline.com/author/avanos-mediacal-cortrak-2lqzs989/
     
 
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