Notes

Avanos Medical faces Class I recall due to feeding tube system connection up to 23 deaths.

After seven years of unlucky luck for Avanos Medical's feed tube inserter, the FDA has handed down its most serious designation for an immediate recall of the device.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet with an external receiver as well as a display monitor. The system provides a live feed of medical tubes being placed into patients' stomachs or small bowels. This allows for an improvement in tip placement accuracy as well as the elimination of any complications.

Avanos launched an earlier year for all Cortrak*2 devices which were in use between January 2021 to January 2022. https://aacnjournals.org/ajcconline/article/26/2/149/3230/Cortrak-Assisted-Feeding-Tube-Insertion-A The total number of affected devices was 630. devices, which was distributed for the first time from April 2016 until the beginning of 2016.

https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system The safety event isn't a recall in the literal sense: Avanos is not asking healthcare providers to send the devices back to the manufacturer instead, they want to make sure they're using them in a safe manner.

If a feeding tube is not correctly installed, it may harm the vocal cords, lungs, or trachea, potentially leading to grave injury or even death. https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/ According to the FDA, Avanos received reports of 23 deaths, and 60 injuries since 2015, all of which were related to the FDA's usage of the Cortrak*2 system for guiding the installation of a feeding tube.

Some of the injuries reported include respiratory failure and collapsed lung as well as lung infections, pleural effusion and holes in the walls of the stomach, bowel, and lungs.

In the March 21 field correction notice, the Georgia-based company reminded users to "confirm the use of nasogastric or Nasoenteric tubes as per guidelines of the institution" per the FDA. feeding tube placement Avanos asked users to add the safety announcement to the operating manual for the system and verify that they have notified Avanos that the change was approved.

Avanos has announced it will soon issue updated labeling for the device, which will include the direction to determine the location of the tube in line with their facility's policies before using the system to help to install the tube.

This marks the second warning the FDA has issued this year in relation to feeding tubes for the enteral system. The FDA issued a safety announcement in February warning parents, healthcare providers, and children of the risk of strangulation from feeding tubes.

This notice was issued due to two deaths that were reported in 2021. https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ The notice was issued following two deaths in 2021. In both instances the tubing system was discovered to have been placed around the necks of patients under the age 2.

"While the FDA believes that strangulation caused by enteral feeding tube tubing in children is rare," the agency noted in the announcement. It suggested that other similar incidents may not have been reported yet to the FDA.


Read More: https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/