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Avanos Medical recalls Cortrak*2 EAS after reports of injury and death due to tube malfunctions.
The US Food and Drug Administration has identified Avanos Medical's Cortrak*2 entry access system (EAS) as a recall as Class II recall.
The Class 1 recall is the most severe among three classes.
Avanos Medical Avanos Medical recalls Cortrak*2 EAS following reports of injuries and deaths due to the wrong placement of nasogastric and nasoenteric tubes.
The device is intended to aid medical professionals who are trained to place medical feeding tubes in patients and offer real-time location information on tube placement.
https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement However, incorrectly placed nasogastric/nasoenteric pipes can cause damage to the vocal cords, or trachea. This can lead to grave injuries or even death.
The company has recall 629 devices, which were sold in the US between 1 April 2016 to 1 January 2022.
The company recall communication stated that 60 patients suffered injuries and 23 were killed due to misplacement in nasogastric tubes while making use of Cortrak* 2 EAS.
Avanos Medical is updating the marking on the device following the recall. This will include an update of the instructions on use and intended use of Cortrak* 2 EAS.
Avanos Medical feeding tube The updated guidelines require that users confirm the location of tubes based on protocols issued by their institutions before using the tubes.
https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Avanos Mediacal Cortrak 2 Based in Alpharetta, Georgia, US, Avanos Medical focuses on manufacturing clinical medical devices. The company markets its recognised brands in over 90 countries.
The company reached an agreement with OrthogenRx to acquire the company in a $160 million transaction. Avanos Medical concluded the acquisition on January 20th.
Avanos Medical feeding tube
My Website: https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas
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