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Avanos Medical pulled Cortrak*2 EAS off service following reports of injuries and deaths caused by tube missing.
The US Food and Drug Administration has identified the Cortrak*2 of Avanos Medical's enteral access system (EAS) to be recalled as an Class II recall.
Avanos Medical feeding tube A Class I Recall is the most serious kind out of three classes.
Avanos Mediacal Cortrak 2 Avanos Medical recalled Cortrak* 2 EAS after incidents of injury and deaths caused by nasoenteric and Nasogastric tube misplacements.
The device is able to assist health professionals with the placement of medical feeding tubes in patients. It also provides in real-time information about tube placement.
However, improper placement of nasogastric and nasoenteric tubes can damage a patient's vocal cords or trachea, lungs, or vocal cords, resulting in serious injuries or even death.
In total, the company has recalled 629 devices that were distributed in the US between 1 April 2016 to 1 January 2022.
According to the recall announcement issued by the company, there were 60 injuries and 23 deaths during 2015 because of the incorrect placement of nasogastric feeding tubes when using the Cortrak* 2 EAS.
https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Avanos Medical feeding tube Avanos Medical will make the needed changes to the labeling of the device following the recall. This includes an update of the instructions and the planned applications of Cortrak* 2 EAS.
The updated guidelines instruct users to check the placement of tubes as per the guidelines of the institution's prior to use.
Avanos Medical has its headquarters in Alpharetta Georgia. Avanos Mediacal Cortrak 2 Its brands are available in more than 90 countries.
The company signed a $160m agreement in December of last year to acquire OrthogenRx. Avanos Medical closed the acquisition on January 20th.
Avanos Medical feeding tube
Homepage: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
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