Notes

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

Avanos Medical pulled Cortrak*2 EAS off service following reports about injuries and deaths related to tube missing.

Avanos Medical The US Food and Drug Administration has confirmed Avanos Medical's Cortrak*2 enal Access System Recall (EAS) as a Class I recall.

The most severe of the three types is the Class I recall.

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

Avanos Medical feeding tube The device is intended to aid health care professionals place medical feeding tubes on patients.

But, incorrect positioning of nasogastric/nasoenteric tubes can result in severe injuries or even death.

Overall, the company has recalls 629 devices distributed across the US between 1 April 2016 to 1 January 2022.

According to the recall communication the company has stated that as of 2015, there had been more than 60 injuries and 23 deaths resulting from the incorrect placement or the use of a nasogastric feeding tube while using the Cortrak* 2 EAS.

Avanos Medical will revise the labelling after the recall. This will include the updating of Cortrak*2 EAS's instructions as well as the intended use.

Users are also directed to verify that tubes have been placed according to protocols of the institution before they make use of them.

Cortrak 2 eternal access system Avanos Medical's headquarters are located in Alpharetta Georgia USA. Avanos Medical feeding tube They focus on the manufacturing of medical equipment. Avanos Medical's well-known brands are accessible in more than 90 countries.

Avanos Medical Avanos Medical The company signed a $160 million agreement last December to acquire OrthogenRx. Avanos Medical feeding tube Avanos Medical closed on the acquisition in January.


Here's my website: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system