Notes

Avanos Medical faces a Class I recall for its the feeding tube system linked to 23 deaths that occurred in 2015

The FDA has given its most severe warning in relation to the recall of Avanos Medical’s enteral feeding tube positioning system.

Avanos Medical feeding tube Cortrak*2 Enteral Access System contains an electronic stylet and an external receiver. Cortrak 2 eternal access system The system provides a live feed of medical tubes being inserted in patients' stomachs or small bowels. This allows for improvement of tip placement accuracy and the reduction of complications.

Avanos was not satisfied with its mission and launched a recall of all Cortrak*2 units between January 2021 and January 2022. The recall included approximately 630 units distributed in total between April 2016 and the beginning this year.

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The safety incident isn't a recall in the literal sense: Avanos is not asking health professionals to return the devices back to the manufacturer, but rather to ensure they're using them correctly.

A feeding tube that is not properly placed could result in damage to the vocal cords, lungs, or trachea. This could lead to serious injuries, or death. Cortrak 2 eternal access system Avanos has reported the deaths of 23 people and 60 injuries cases since 2015, according to FDA. This is all because of the FDA's Cortrak*2 system which directs the placement of feeding tubes.

There are several injuries that have been reported such as respiratory failure, collapsed lung, lung infections.

According to FDA, Georgia-based company has reminded patients in its March 21 Field Correction Notice to "confirm placements of nasogastric & Nasoenteric tubes in accordance with the policies of the institution". Avanos asked users to attach the safety notification to the operating manual for the system and confirm with Avanos that the change was approved.

Avanos stated that it will soon issue updated labeling for its device. https://aacnjournals.org/ajcconline/article/29/1/22/30624/Pneumothoraces-Prevented-With-Use-of It will also include instructions for locating the position of a tube in accordance to their facility's policies.

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This is the FDA's second caution regarding the use of an enteral tube for feeding use. The FDA released an safety communication in February, warning healthcare professionals and parents about the risk of strangulation in the event that children are using feeding tubes.

https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview This notice was issued due to two deaths that were reported in 2021. feeding tube placement In both instances, a tubing system was found to be wrapped around the neck of a child who was less than two years old when they weren't directly watched by the medical staff or caregivers.

"While the FDA believes that deaths or serious injuries caused by strangulation caused by enteral food set tubing in children are rare healthcare professionals and caregivers should know that these events can and will happen," the FDA noted in the notice.


Homepage: https://aacnjournals.org/ajcconline/article/29/1/22/30624/Pneumothoraces-Prevented-With-Use-of