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Avanos Medical pulled Cortrak*2 EAS off service following reports of injuries and deaths related to tube misplacements.
The US Food and Drug Administration has confirmed Avanos Medical's Cortrak*2 enal Access System Recall (EAS) as a Class I recall.
A Class I recall is a reference to the most severe of the three classes.
Avanos Mediacal Cortrak 2 Avanos Medical recalled Cortrak* 2 EAS in the wake of reports of injuries and deaths caused by nasoenteric and Nasogastric tube misplacements.
The device allows trained healthcare professionals to insert medically-approved feeding tubes into patients.
But, improperly placed nasogastric/nasoenteric pipes could result in damage to vocal cords or the trachea. This can lead to serious injuries or even death.
Avanos Medical feeding tube In total, the company has been able to recall 629 devices distributed in the US between 1 April 2016 to 1 January 2022.
https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical According to the recall communication the company has stated that as of 2015, there had been 60 injuries and 23 deaths as a result of the incorrect placement or misuse of the Nasogastric feeding tubes when making use of the Cortrak* 2 EAS.
Avanos Medical, following the recall, will be updating the labeling of the device. feeding tube placement This will include updating the instructions and intended applications of Cortrak* 2 EAS.
Users should also ensure that the tubes are placed according to protocols of the institution prior to make use of them.
Avanos Medical, based in Alpharetta Georgia, USA is a producer of medical devices that are clinically proven. It sells its brands in over 90 different countries.
Cortrak 2 eternal access system Last December, the business reached an agreement to purchase OrthogenRx with the amount of $160 million. Avanos Medical concluded the acquisition on 20th January.
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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