Notes

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

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

Avanos Mediacal Cortrak 2 Cortrak*2 Enteral Access System features an electromagnetic stylet that includes an external receiver, a display monitor and an electronic receiver. It provides a continuous feed of medical feeding tubes being inserted into patients' stomachs or small bowels. This permits an improvement in tip placement accuracy and the elimination of any complications.

Avanos Mediacal Cortrak 2 Avanos started the recall earlier in the year for all Cortrak*2 equipment that was used between January 2021 and Jan 2022. There were more than 630 devices originally distributed between April 2016 through the beginning.

The safety issue isn't an recall, in the strict sense. Avanos Medical Avanos doesn’t ask healthcare providers to return the devices at the factory. Avanos wants them to use the devices correctly.

A tube for feeding that has not been correctly inserted can cause serious injury and even cause death. According to the FDA, Avanos received reports of 23 deaths, and 60 injuries since 2015, all of which were related to the FDA's use of the Cortrak*2 system to guide the placement of the feeding tube.

There are many injuries that have been documented, including respiratory failure, lung infection and collapsed lung.

Avanos Medical The FDA issued a 21 March field correction notice in which the Georgia-based firm reminded users to verify the positioning of nasogastric tube and Nasoenteric pipes in accordance with institutional policies. They've also been instructed to add the safety note to the operating manual of the system and confirm with Avanos that they have received the latest version of the notice.

Avanos Medical feeding tube Avanos said it will soon release a new labeling system for the device that will contain the directions to determine the tube's location in accordance with their facility's policies before making use of the system to assist set up the tube.

This is the FDA’s second warning regarding enteral feeding tubes this year. In February, the agency put out an safety message informing healthcare professionals and parents of the risk of strangulation in children who use feeding tubes.

The notice came after two deaths in 2021. Every time, a tubing system was inadvertently wrapped around a child who was less than two years old while they were not closely monitored by hospital staff or caregivers.

Avanos Mediacal Cortrak 2 "While the FDA believes that the risk of serious injury or death due to strangulation caused by tubing for enteral feeding in children is rare Healthcare professionals and caregivers should be aware that these events can and do occur," the agency said in the announcement, suggesting that other similar incidents may not had been reported to the FDA.


My Website: https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas