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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This issue is responsible for at least 60 injuries , and 23 deaths.

The FDA has designated this as a Class I Recall, which is the most serious type. The use of these devices could result in serious injuries or even death.

https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf Sam Brusco, Associate Editor05.16.22

The FDA has identified Avanos Medical's recall of their Cortrak*2 entry access system. 629 devices, distributed from 2016 and 2022, were recalls by the U.S. starting on March 21.

Cortrak*2 helps clinicians place medical feeding tubes inside the stomach or small bowels of patients who require to be fed by the tube.

The recall was initiated because of reports of injuries and deaths in patients due to mistakes in the placement of gastric or nasocentric tubes. https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/ Avanos Medical The device is used to insert the tubes. Avanos Medical If the tube is not properly placed, it could cause severe injuries or even death.

According to AvanosSafety Communication, there were 60 deaths and 23 injuries resulting from this issue. https://www.medicaltubingandextrusion.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ Pneumothorax (perforation), pneumothorax (perforation) and pneumonia and pleural effusion were all listed as adverse events.

Cortrak 2 eternal access system Cortrak*2 will use the recall to update its guidelines for use and intended uses. Avanos Medical It will instruct users to ensure the tube is placed using institutional protocols before delivering nutrition.

Clinicians are also advised to attach the field correction note to the operating manual and return the acknowledgement forms included with the notification to Avanos. https://content.govdelivery.com/accounts/USFDA/bulletins/317bc54 Avanos plans to provide users with new labeling and confirmation of the placement of tubes according to institutional policies before usage.


Homepage: https://content.govdelivery.com/accounts/USFDA/bulletins/317bc54
     
 
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