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Avanos Medical pulled Cortrak*2 EAS off service following reports of injuries and deaths due to tube missing.
https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause#:~:text=Reason%20for%20Recall,to%20help%20with%20their% 20placement. Cortrak 2 enteral access system The US Food and Drug Administration has classified Avanos Medical's Cortrak*2 enteral Access System (EAS), as a Class 1 recall.
The Class 1 recall is the most severe of the three classes.
Cortrak 2 eternal access system Avanos Medical pulled Cortrak* 2 EAS out of service due to patient deaths and injuries due to nasogastric tubes misplacements.
feeding tube placement The device allows trained health professionals to insert medical feeding tubes inside patients.
However, incorrectly placed nasogastric/nasoenteric pipes can cause damage to vocal cords or trachea. This can lead to severe injuries, or even death.
Avanos Medical The company has now removed 629 devices from the US that were sold between April 1st, 2016 and 1 January 2022.
According to the company's recall communication, there were sixty injuries and 23 deaths in 2015 as a result of the misplacement of nasogastric tube feeding tubes in the course of using the Cortrak* 2 EAS.
Avanos Medical will revise the labelling after the recall. This will include updated instructions on how to use the device and the intended use of the Cortrak*2 EAS.
https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ The updated guidelines require users to verify the position of tubes according to protocols issued by their institutions before using them.
The headquarters of Avanos Medical is in Alpharetta Georgia the United States of America. They are a specialist in the production of medical devices. The company has more than 90 markets that are branded with its brands.
The company reached an agreement with OrthogenRx to purchase the company in a $160m transaction. Avanos Medical completed the acquisition on January 20.
Website: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement
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