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Avanos Medical pulled Cortrak*2 EAS off service following reports of injuries and deaths due to tube misplacements.
The US Food and Drug Administration has recognized the Cortrak*2 of Avanos Medical's Enal Access System Recall (EAS) in a Class I recall.
A Class I can remember is considered to be the most serious out of the 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 designed to help medical professionals who are trained to place medical tube feedings in patients and offer real-time location information on tube placement.
However, the wrong placement of nasogastric and nasoenteric tubes could damage the vocal cords of a patient, lungs or trachea and cause severe injuries or even death.
https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ The company has recall 629 units, which were sold in the US from 1 April 2016 to 1 January 2022.
The company also said in a recall communication that there were 60 injuries and 23 patients who died since 2015 due to the feed tubes that were not properly placed that were connected to the Cortrak* 2 EAS.
Avanos Medical, following the recall, will revise the device’s labelling. Avanos Medical This includes updating the instructions for use as well as the intended use of Cortrak*2 EAS.
https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm Users should also confirm that the tubes have been put in the correct manner according to the guidelines of the institution before they use.
Avanos Medical is based in Alpharetta (Georgia), USA. Its focus is on the production of medical devices. Cortrak 2 eternal access system Avanos Medical has over 90 markets to sell its renowned brands.
Avanos Mediacal Cortrak 2 In December, the company entered into an agreement worth $160 million to purchase OrthogenRx. Avanos Medical completed the acquisition on January 20.
Website: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm
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