FDA has declared Avanos Medical's Cortrak*2 EAS Recall Class I

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05 July 2022

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Avanos Medical recalls Cortrak*2 EAS in the wake of reports of injury and even death caused by tube malfunctions.

The US Food and Drug Administration has identified the Cortrak*2 of Avanos Medical's enteral access system (EAS) to be recalled as a Class II recall.

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

Avanos Medical recalled Cortrak* 2 EAS after incidents of injury and patient deaths caused by nasoenteric and Nasogastric tube malfunctions.

This device can be used to assist trained health professionals with the placement of medically-approved feeding tubes for patients. Avanos Mediacal Cortrak 2 https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html It also gives real-time information regarding tube placement.

But, improperly installed nasogastric/nasoenteric pipe could result in damage to vocal cords, or the trachea. This could result in grave injuries or even death.

Avanos Mediacal Cortrak 2 Overall, the company has been able to recall 629 devices sold in the US between April 1st, 2016 and 1 January 2022.

According to the recall communication, the company stated that since 2015 there have been 60 injuries and 23 deaths resulting from the misplacement or misuse of the Nasogastric feeding tubes when using the Cortrak* 2 EAS.

Avanos Medical, following the recall, will update the device’s labelling. This will include updating instructions for use and intended usages of the Cortrak*2 EAS.

Cortrak 2 eternal access system Users are also directed to verify that tubes have been placed according to protocols of the institution prior to use.

https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns Avanos Mediacal Cortrak 2 Avanos Medical, based in Alpharetta Georgia, USA is a producer of clinical medical devices. The company's recognized brands are sold in over 90 countries.

In December of last year Avanos Medical entered into an agreement worth $160 million to purchase OrthogenRx. Avanos Medical closed on the acquisition in January.

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