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Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries and deaths from tube misplacements.
The US Food and Drug Administration has confirmed Avanos Medical's Cortrak*2 enal Access System Recall (EAS) as Class I recall.
The most dangerous of the three types is the Class I recall.
https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ Avanos Medical recalls Cortrak*2 EAS following reports of injuries and even death caused by incorrect placements of nasogastric or nasal tubes.
https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical The device allows skilled healthcare personnel to place medically-approved feeding tubes into patients.
However, incorrectly placed nasogastric/nasoenteric tubes could result in damage to vocal cords and the trachea. feeding tube placement This could lead to grave injuries or even death.
The recall affects 629 devices sold in the US between 1 February 2016 to 1 January 2022.
The communication regarding the recall from the company added that there had been sixty injuries and 23 deaths in patients since 2015 due to the misplacement of Nasogastric feeding tubes that were used with the Cortrak* 2 EAS.
In the wake of the recall, Avanos Medical will update the device's labelling. https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement This will include updating the instruction on how to use the device as and the intended uses for Cortrak*2 EAS.
The updated guidelines instruct users to ensure that the tube is set up according to the protocol of the institution before to its use.
Based in Alpharetta, Georgia, US, Avanos Medical focuses on the production of medical devices that are clinically proven. The company's recognized brands are sold in more than 90 countries.
Last December, the business entered into an agreement to buy OrthogenRx in the amount of $160 million. Avanos Medical closed the acquisition on the 20th of January.
Homepage: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
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