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Avanos Medical recalls Cortrak*2 EAS following reports of injuries and death due to tube misplacements.
Avanos Medical The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical of Cortrak*2 Ental Access System, (EAS) as an I class recall.
The most serious of the three types is a Class I remember.
Avanos Medical recalls Cortrak*2 EAS after reports of injury and deaths due to the wrong placement of nasogastric and nasoenteric tubes.
The device is designed to assist health professionals put medical feed tubes on patients.
But, the incorrect placement of nasogastric and nasoenteric tubes could cause damage to a patient's vocal cords, lungs or trachea which can cause serious injuries or even death.
The recall covers 629 devices sold in the US between February 1st, 2016 and 1 January 2022.
Avanos Medical feeding tube According to the recall announcement issued by the company, there were 53 deaths and 60 injuries in 2015 as a result of the incorrect placement of nasogastric feeding tubes during use of the Cortrak* 2 EAS.
Avanos Medical, following the recall, will revise the device's labelling. Cortrak 2 eternal access system This will include the updating of Cortrak*2 EAS's instructions as well as the intended use.
The revised guidelines require that users confirm the placement of tubes in accordance with protocols from their respective institutions before making use of the tubes.
Based in Alpharetta, Georgia, US, Avanos Medical focuses on manufacturing clinical medical devices. The company sells its brands in over 90 different countries.
The company agreed to buy OrthogenRx for $160 million in December. Cortrak 2 eternal access system Avanos Medical concluded the acquisition on January 20th.
https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical
Homepage: https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical
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