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FDA has identified Avanos's Cortrak*2 EAS recall Class I

Avanos Medical recalls Cortrak*2 EAS after reports of injury and death due to tube incorrect placement.

The US Food and Drug Administration (FDA), has declared the recall of Avanos Medical of Cortrak*2 Ental Access System, (EAS), as a class I recall.

A Class 1 recall is the most serious of three classes.

Avanos Medical called off Cortrak* 2, EAS, due to deaths and injuries resulting from misplacements of nasogastric tubs.

The device is able to assist trained healthcare professionals to insert medically-approved feeding tubes for patients. Cortrak 2 eternal access system It also provides real-time details about the placement of tubes.

Avanos Medical feeding tube However, incorrectly installed nasogastric/nasoenteric pipe can cause damage to the vocal cords, or trachea. This could result in grave injuries or even death.

The recall affects 629 devices that were available in the US between 1 February 2016 and 1 January 2022.

The recall notice from the company stated that 60 patients were injured and 23 were killed due to misplacement in nasogastric tubes while using Cortrak* 2 EAS.

Avanos Medical After the recall Avanos Medical will update the device's labelling. This will include changing the instructions for Cortrak*2 EAS as well as its intended uses.

Cortrak 2 eternal access system These updated guidelines require users to check the placement of tubes as per the guidelines of the institution's prior to using the tube.

Based in Alpharetta, Georgia, US, Avanos Medical focuses on making medical devices for clinical use. The company's recognized brands are available in over 90 countries.

Avanos Mediacal Cortrak 2 The company entered into a $160m contract in December last year to purchase OrthogenRx. Avanos Mediacal Cortrak 2 Avanos Mediacal Cortrak 2 Avanos Medical concluded the acquisition on the 20th of January.

Cortrak 2 eternal access system
Here's my website: https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns
     
 
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