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

Avanos Medical called off Cortrak* 2 EAS in response to patient injury and deaths caused by tube displacements.

https://notes.io/q3DMD The US Food and Drug Administration has acknowledged Avanos Medical's Cortrak*2 Enal Access System Recall (EAS) in a Class I recall.

A Class I recall is a reference to the most difficult of three classes.

Avanos Medical pulled Cortrak* 2 EAS off service following patient deaths and injuries due to nasogastric tubes misplacements.

Avanos Mediacal Cortrak 2 The device was designed to assist trained health care workers in placing medical feed tubes in patients.

Avanos Medical However, the incorrect placement of the nasogastric, or nasoenteric tube could cause severe injury or death.

The company recalls 629 devices sold in the US between January 2016 and January 2022.

The recall notification from the company said that 60 patients were injured and 23 were killed due to the wrong placement of nasogastric tubes when making use of Cortrak* 2 EAS.

Avanos Medical will revise the labelling after the recall. This will include an update of the instructions and the planned applications of Cortrak* 2 EAS.

The revised guidelines require users to confirm the placement of tubes according to protocols issued by their institutions prior to using the tubes.

Avanos Medical is based in Alpharetta (Georgia) in the United States. Avanos Medical It specializes in the production of medical devices. https://anotepad.com/notes/e9ht4a36 Avanos Medical Avanos Medical sells its products across more than 90 countries.

The company signed an agreement to purchase OrthogenRx for $160 million in December. Avanos Medical closed the acquisition on the 20th of January.


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