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Avanos Medical called off Cortrak* 2 EAS in response to the patient deaths and injuries caused by tube misplacements.
The US Food and Drug Administration (FDA) has designated the recall by Avanos Medical of Cortrak*2 Ental Access System, (EAS), as an I class recall.
A Class I remember is considered to be to be the most important of the three classes.
Avanos Medical has recalled Cortrak*2 EAS due to reports of injuries or deaths from nasogastric tube misplacements.
The device is designed to assist health professionals place medical feeding tubes on patients.
https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement Avanos Medical Avanos Medical However, improper positioning of nasogastric/nasoenteric tubes can cause severe injuries, or even death.
The company has now been able to recall 629 devices in the US that were distributed between April 1st, 2016 and 1 January 2022.
According to the company's recall notice, 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 make the necessary updates to the labeling of the device following the recall. This includes updating the directions for use , as and the intended uses for Cortrak*2 EAS.
These revised guidelines direct users to ensure that the tube is placed as per the guidelines of the institution's prior to using the tube.
The headquarters of Avanos Medical is in Alpharetta Georgia America. They focus on the manufacturing of medical equipment. Avanos Medical feeding tube The company's products are distributed across more than 90 countries.
Avanos Medical feeding tube The company signed a $160 million contract in December last year to purchase OrthogenRx. Avanos Medical closed the acquisition on 20 January.
Avanos Medical
Homepage: https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf
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