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Avanos Medical called off Cortrak* 2 EAS in response to patient death and injuries caused by tube misplacements.
The US Food and Drug Administration has recognized Avanos Medical's Cortrak*2 Enal Access System Recall (EAS) as Class I recall.
https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas A Class I recall refers to the most severe of three classes.
Avanos Medical recalls Cortrak*2 EAS following reports of injuries and death due to the wrong placement of nasogastric and nasoenteric tubes.
The device allows trained health professionals to insert medically-approved feeding tubes into patients.
But, the incorrect placement of nasogastric/nasoenteric tubs can result in severe injuries or even death.
The company has removed 629 devices from the US that were sold between 1 April 2016 - 1 January 2022.
Avanos Mediacal Cortrak 2 According to the recall communication, the company stated that as of 2015, there had been 60 injuries as well as 23 deaths due to the misplacement or misuse of the Nasogastric feeding tubes when using the Cortrak* 2 EAS.
After the recall Avanos Medical will update the labeling of the device. This will include updating the instructions for use and intended usages of the Cortrak*2 EAS.
The new guidelines direct users to confirm that the tube has been set up according to the protocol of their institution prior to its use.
Avanos Medical is based in Alpharetta (Georgia) in the United States. Its focus is on the manufacturing of medical devices. https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf Avanos Medical has over 90 markets to sell its renowned brands.
feeding tube placement The company entered into a $160m agreement last December to acquire OrthogenRx. Cortrak 2 eternal access system Avanos Medical completed the acquisition on the 20th of January.
Read More: https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf
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