Notes

Avanos Medical is facing a Class I recall due to issues with the feeding tube system which have resulted in 23 deaths since the year 2015.

After seven years of failures with Avanos Medical's Enteral Feeding Tube Placement System, the FDA has designated the most severe category for recalls.

Avanos Medical Cortrak*2 Enteral Access System contains an electronic stylet, as well as an external receiver. It can be utilized in conjunction with the system to provide a live feed that shows the procedure of inserting a medical feeding tube in the stomach of an individual. The procedure is performed with the aim of improving accuracy and reducing complications.

In spite of that mission however, the system has been linked to dozens of injuries to patients, causing Avanos to launch an recall in January of all Cortrak*2 devices used between January 2021 and January 2022--totaling nearly 630 devices first distributed between April 2016 and the beginning of this year.

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, instead, they want to make sure they're using them in a safe manner.

Avanos Medical A tube for feeding that has not been properly inserted could cause serious injuries and even cause death. Avanos was informed of 23 deaths and 60 injuries in 2015 by the FDA. feeding tube placement https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical The incidents were all connected to the Cortrak*2 system, which guides the placement of the feeding tube.

There are many injuries reported which include respiratory failure, lung infections and collapsed lung.

The FDA has reminded patients that they need to confirm the the placement of a nasogastric or nasoente tube according to their institutional guidelines in the March 21 field correction notice. Avanos has requested that users attach a safety notice to their operating manuals and verify that they have received the latest.

Avanos stated that it will soon issue new labeling guidelines for its device. This will include directions for locating the position of a tube according to the guidelines of their facility.

Avanos Medical feeding tube This is the FDA's second caution in relation to tube feeding through the stomach. The FDA issued the safety announcement in February that warned parents and healthcare professionals of the risk of strangulation when children are using feeding tubes.

Two deaths in 2021 were disclosed in the announcement. In both instances, a tubing system was found to accidentally wrap around the neck of patients under the age of two while they weren't being directly observed by their medical staff or caregivers.

"While the FDA believes strangulation with enteral feed set tubing in children is uncommon healthcare professionals must be aware of such incidents," the agency stated in its notice. This suggests that similar instances may not have been reported to the FDA.

Cortrak 2 eternal access system
Read More: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement