Notes

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

The FDA has issued the most extreme warning regarding the recall of Avanos Medical’s enteral feeding tube positioning system.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an external receiver, and a screen. It provides a continuous feed of medical feeding tubes being inserted in patients' stomachs or small bowels. This facilitates an improvement in tip placement precision and reduction of complications.

Avanos issued a recall earlier in the year to all Cortrak*2 devices that were used from January 2021 to January 2022. This totaled nearly 630 devices. They were distributed for the first time between April 2016 to the beginning of the year.

The safety event isn't a recall , in the literal sense: Avanos is not asking health professionals to return the device back to its manufacturer instead, it's a way to make sure that they're using them correctly.

A feeding tube that is not properly installed can result in damage to vocal cords or the tracheas. Avanos has reported the deaths of 23 people and 60 injuries cases since 2015 according to the FDA. All of this was because of the FDA's Cortrak*2 system, which guides placement of feeding tubes.

The injuries reported include respiratory failure as well as lung infections, collapsed lung the pleural effusion and holes in the lungs' walls, esophagus and bowel.

Cortrak 2 eternal access system In its March 21 field correction notice, the Georgia-based company advised users to "confirm placement of nasogastric and Nasoenteric tubes as per institutional policies," according to the FDA. Avanos asked users to add the safety announcement to the operating manual for the system and verify that they have notified Avanos that the update was accepted.

Avanos announced that it will soon issue new labeling guidelines for its product. It will also include instructions to indicate the location of a tube according to the guidelines of their facility.

Avanos Medical The FDA has issued a second warning regarding enteral feeding tubes this year. https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system In February, the FDA issued the safety advisory to parents and healthcare providers about the risk of strangulation among children who use feeding tubes.

Avanos Medical feeding tube Two deaths occurred in 2021 and were not reported to the notice. Each case included a tube that was tied around the neck of a baby less than 2 years old, while the child was not being observed by staff at the hospital.

"While the FDA considers strangulation caused by enteral feed set tubing in children is uncommon healthcare professionals must be aware of such incidents," the agency stated in the notice. This suggests that similar cases might not have been reported to the FDA.

Avanos Medical
Here's my website: https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/