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Avanos Medical pulled Cortrak*2 EAS from service after receiving reports about injuries and deaths related to tube missing.
The US Food and Drug Administration has classified Avanos Medical's Cortrak*2 Entral Access System (EAS), as a Class 1 recall.
https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html A Class I recall is considered the most serious out of all three classes.
Avanos Medical Avanos Medical recalled Cortrak* 2 EAS following reports of injuries and patient deaths due to nasoenteric or Nasogastric tube malfunctions.
https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system The device allows skilled healthcare personnel to place medical feeding tubes in patients.
But, incorrect placement of nasogastric/nasoenteric tubs can cause serious injuries or even death.
Avanos Medical The recall covers 629 devices sold in the US between February 1st, 2016 to 1 January 2022.
According to the company's recall communication it was reported that there were 60 injuries and 23 deaths in 2015 due the misplacement of nasogastric tube feeding tubes when using the Cortrak* 2 EAS.
Avanos Medical feeding tube feeding tube placement Avanos Medical will make the necessary updates to the labeling of the device following the recall. This includes updating Cortrak*2 EAS's instructions and expected uses.
The updated guidelines also instruct users to verify the placement of their tubes based on the respective institution's protocols before usage.
Avanos Mediacal Cortrak 2 Avanos Medical, based in Alpharetta Georgia, USA, is a manufacturer of clinical medical devices. The company's products are distributed across more than 90 countries.
Last December, the business signed an agreement to acquire OrthogenRx in a $160m deal. Avanos Medical feeding tube Avanos Medical concluded the acquisition on 20th January.
Read More: https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/
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