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Avanos Medical recalled Cortrak* 2 EAS in the wake of reports of injuries and patient deaths due to tube misplacements.
The US Food and Drug Administration has confirmed the Cortrak*2 of Avanos Medical's Enal Access System Recall (EAS) as Class I recall.
A Class I can remember is considered to be the most serious out of the three classes.
Avanos Mediacal Cortrak 2 Avanos Medical pulled Cortrak* 2 EAS off service following death and injuries of patients due to misplacements of nasogastric tubes.
The device is able to assist trained healthcare professionals to insert medical feeding tubes in patients. Avanos Medical feeding tube Avanos Mediacal Cortrak 2 It also provides real-time details about the placement of tubes.
However, incorrectly placed nasogastric/nasoenteric tubes can cause damage to vocal cords, or the trachea. This could result in serious injuries or even death.
The company has since recalled 629 devices from the US that were distributed between 1 April 2016 - 1 January 2022.
The company also stated in a recall announcement that there have been sixty injuries and 23 people killed since 2015 because of the misplacement nasogastric feed tubes when using the Cortrak* 2 EAS.
Cortrak 2 eternal access system Avanos Medical is updating the labelling on the device after the recall. Avanos Medical This includes updating the instructions on how to use the device as well as the intended use of Cortrak*2 EAS.
Avanos Mediacal Cortrak 2 Users should also verify that tubes have been installed in accordance with the protocols of the institution prior to make use of them.
Avanos Medical, based in Alpharetta Georgia, USA is a maker of medical devices that are clinically proven. The company sells its brands in more than 90 different countries.
Avanos Mediacal Cortrak 2 Avanos Mediacal Cortrak 2 The company entered into a $160m contract in December last year to purchase OrthogenRx. Avanos Medical closed the acquisition on the 20th of January.
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