Notes

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

After seven years of poor experience with Avanos Medical's insertal feeding tube placement system for children The FDA has issued the most severe warning regarding the recall of this device.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet with an external receiver as well as a display monitor. The system is able to be used in conjunction to show a live stream that shows the procedure of inserting a feeding tube into the stomach of an individual. This procedure is carried out to improve accuracy and reducing complications.

https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ Avanos launched a recall earlier in the year for all Cortrak*2 devices which were in use between January 2021 and January 2022. This totaled nearly 630 devices, which was first distributed between April 2016 to the beginning of 2016.

The safety event isn't a recall in its literal sense: Avanos does not ask health professionals to return the devices back to the manufacturers. Instead, it wants to make sure users are making use of the devices properly.

An incorrectly placed feeding tube could cause damage to vocal cords and lungs. Avanos Medical feeding tube https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause It can also result in grave injury or even death. Avanos was alerted of 23 deaths and 60 injuries in the year 2015 by the FDA. These events were all connected to the Cortrak*2 system that guides the installation of the feeding tube.

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

In the March 21 field correction note, the Georgia-based business advised users to "confirm the placement of nasogastric as well as Nasoenteric tubes in accordance with guidelines of the institution" according to the FDA. Avanos has also asked them to attach the safety note to the operating manual of the system and confirm that they have received the updated.

Avanos announced that they'll soon release new labeling on the device. It will include the directions to put the tube in accordance with their policies.

This is the FDA's second warning of the year for enteral feeding tubes. Avanos Medical The FDA issued a safety communication in February that warned parents, healthcare providers, and children about the possibility of strangulation through tubes feeding food.

The announcement came in the wake of two deaths in 2021. Every time, a tubing system was wrapped around a child under two years old, even though they were not being closely watched by hospital staff or caregivers.

"While FDA believes that death due to strangulation caused by enteral feeding tubing used for children is extremely rare but it is important that caregivers and healthcare providers are aware that events like this could and do occur," the FDA stated in the announcement. https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ The FDA suggested that similar cases may not have been reported yet.


Here's my website: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause