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

Avanos Medical recalled Cortrak* 2 EAS in the wake of incidents of injury and patient deaths due to tube missing.

The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak*2 Enteral Access System (EAS) as Class I recall.

A Class I recall refers to the most severe of the three classes.

Avanos Medical recalled Cortrak* 2 EAS after reports of injuries and patient deaths due to nasoenteric nasogastric tube misplacements.

This device can be used to aid trained healthcare professionals to insert medically-approved feeding tubes for patients. It also provides in real-time information about tube placement.

Avanos Medical However, improper placement of nasogastric and nasoenteric tubes can damage the vocal cords of a patient, lungs or trachea, resulting in serious injury or even death.

Cortrak 2 eternal access system The company has recall 629 units, which were made available in the US from April 1st, 2016 to 1 January 2022.

Avanos Medical In the recall announcement the company said that as of 2015, there had been 60 injuries and 23 deaths as a result of the incorrect placement or use of nasogastric feeding tube while using the Cortrak* 2 EAS.

Avanos Medical is updating the marking on the device following the recall. This will include updating Cortrak*2 EAS's instructions and intended uses.

These revised guidelines direct users to verify tube placement according to the institution's protocols prior use.

Headquartered in Alpharetta, Georgia, US, Avanos Medical focuses on manufacturing clinical medical devices. The brand's name is available in over 90 countries.

Avanos Mediacal Cortrak 2 The company signed an agreement to purchase OrthogenRx for $160 million in December. Avanos Medical successfully closed the acquisition of OrthogenRx on 20 January.

feeding tube placement
Here's my website: https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf