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Avanos Medical pulled Cortrak*2 EAS off service following reports of deaths and injuries related to tube missing.
Cortrak 2 eternal access system The US Food and Drug Administration has identified Avanos Medical's Cortrak*2 entry access system (EAS) as a recall as a Class II recall.
A Class I can remember is considered to be the most serious out of all three classes.
Avanos Medical pulled Cortrak* 2 EAS from service after the deaths of patients and injuries related to nasogastric tubes misplacements.
The device was developed to aid trained health professionals in putting medical feed tubes into patients.
https://www.fcc.gov/fcc-bin/bye?https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview However, the incorrect placement of the nasogastric, or nasoenteric tubes could cause severe injury or death.
The company recalls 629 devicesthat were distributed in the US from 1 April 2016 to 1 January 2022.
According to the company's recall communication, there were sixty injuries and 23 deaths during 2015 because of the incorrect placement of nasogastric feeding tubes in the course of using the Cortrak* 2 EAS.
Avanos Medical feeding tube Avanos Medical, following the recall, will revise the device's labelling. This will include updating the instructions for use and intended usages of Cortrak*2 EAS.
Users are also advised to confirm that the tubes have been installed in accordance with the protocols of the institution prior to utilize them.
http://pandora.nla.gov.au/external.html?link=https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause The headquarters are located in Alpharetta, Georgia, US, Avanos Medical focuses on the production of medical devices that are clinically proven. The company markets its recognised brands across over 90 countries.
Last December, the company reached an agreement to purchase OrthogenRx in an agreement worth $160 million. feeding tube placement Avanos Medical concluded the acquisition on the 20th of January.
https://independent.academia.edu/BanksBlanchard
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