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Avanos Medical recalls Cortrak*2 EAS in the wake of reports of injury and even death caused by tube misplacements.
The US Food and Drug Administration has classified Avanos Medical's Cortrak*2 Entral Access System (EAS), as a Class 1 recall.
https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ The most severe of the three kinds is the Class I recall.
Avanos Medical called off Cortrak*2, EAS, due to deaths and injuries resulting from the misplacement of tubs for nasogastric surgery.
The device is intended to aid health care professionals to place medical feeding tubes on patients.
But, the incorrect placement of nasogastric and nasoenteric tubes can damage the vocal cords of patients, lungs or trachea, resulting in serious injury or even death.
The company has recalled 629 devices throughout the US between January 2016 to January 2022.
Cortrak 2 eternal access system The recall communication from the company stated that there have been sixty injuries and 23 deaths in patients since 2015 due to the misplacement of Nasogastric feeding tubes that were used with the Cortrak* 2 EAS.
Avanos Mediacal Cortrak 2 Avanos Medical, following the recall, will be updating the device’s labelling. This includes changing the instructions as well as the intended applications for Cortrak* 2 EAS.
https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ These updated guidelines require users to ensure that the tube is placed as per the guidelines of the institution's prior use.
The headquarters are located in Alpharetta, Georgia, US, Avanos Medical focuses on manufacturing clinical medical devices. Avanos Medical sells its products in more than 90 different countries.
Avanos Medical feeding tube The company agreed to acquire OrthogenRx at $160 million during December. Avanos Medical closed the acquisition on the 20th of January.
My Website: https://content.govdelivery.com/accounts/USFDA/bulletins/317bc54
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