Notes

Avanos Medical is facing a Class I recall due to issues with the feeding tube system which have led to the deaths of 23 patients since 2015.

After seven years of failures for Avanos Medical's Enteral Feeding Tube Placing System Avanos Medical's Enteral Feeding Tube Placement System has failed for FDA has designated the most serious class for recalls.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an outside receiver and a display screen. It provides a continuous feed of medical feeding tubes being inserted in patients' stomachs or small bowels. This permits the improvement of tip placement accuracy and the decrease of complications.

Avanos Medical Avanos issued an earlier year, affecting all Cortrak*2 units that were used between January 2021 and January 2022. This totaled nearly 630 devices. They were distributed for the first time between April 2016 to the beginning of the year.

The incident that caused the safety issue isn't a recall in any strict sense. Avanos does not ask healthcare providers for the device to be returned to the manufacturer. It's just to make sure that they're using the device in a safe manner.

An incorrectly placed feeding tube can damage vocal cords and lungs. It can also result in grave injury or even death. Avanos has reported the deaths of 23 people and 60 injuries cases in 2015, according to FDA. This is all because of the FDA's Cortrak*2 system, which guides the placement of feeding tubes.

https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system There are several injuries that have been documented which include respiratory failure, lung infections and collapsed lung.

According to FDA in its March 21 Field Correction Notice, the Georgia-based business asked users to "confirm the placement of the nasogastric (and the nasoenteric) tubes according to institutional policy." They've also been instructed to attach the safety notice to the operating manual for the system and confirm with Avanos that they received the latest version of the notice.

Avanos announced that they'll soon release updated labeling to the device. It will include the direction to place a tube according to their guidelines.

This is the FDA’s second warning regarding the use of enteral feeding tubes this year. The FDA issued a safety communications in February that warned parents, healthcare providers and children about the possibility of strangulation through tubes for feeding.

The notice was issued due to two deaths that were reported in 2021. Cortrak 2 eternal access system Cortrak 2 eternal access system In each case the tubing system was found to accidentally wrap around the neck of patients who was less than two years old even though they were not being monitored by caregivers or hospital workers.

Avanos Medical "While the FDA believes that strangulation due to tube feeding into the enteral system in children is not common," the agency noted in the announcement. It also suggested that similar cases might not have been reported to the FDA.


Read More: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview