Notes

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

After seven years during which Avanos Medical's enteral tube placement system was plagued by unlucky luck and a lack of trust, the FDA handed out its most severe directive for a recall.

Cortrak*2 Enteral Access System contains an electronic stylet and an external receiver. When they are used together it provides a live feed of the placement of an medical tube for feeding into a patient's stomach or small bowel, with an intention of improving the accuracy of the tube's tip positioning and reducing complications.

Avanos was not satisfied with the mission and launched an recall of all Cortrak*2 units between January 2021 & January 2022. Cortrak 2 eternal access system The recall covered approximately 630 units distributed in total between April 2016 and the start of this year.

Avanos Medical The safety issue isn't a recall, in the strict sense. Avanos doesn’t ask healthcare providers to return the devices to the manufacturer. Avanos wants them to make use of the devices in a safe manner.

A tube for feeding that is not correctly inserted can cause serious injury or even death. Avanos Medical Avanos was notified of 23 deaths and 60 injuries in the year 2015 by the FDA. The incidents were all linked to the Cortrak*2 system that guides the placement of the feeding tube.

A variety of injuries have been reported including respiratory failure (collapsed lung) as well as lung infections, pleural effusion, holes in the walls, esophagus, and bowel.

The FDA has reminded patients that they need to confirm the placement of nasogastric or nasoenteric tube according to their institutional guidelines in the March 21 field correction notification. Avanos advised users to include the safety notice in the operation manual of the system and confirm with Avanos that the update was received.

Avanos has indicated that it will soon issue new labeling for the device. It will also include the directions for locating the tube in accordance with their policies for facilities.

This is the FDA's second caution regarding the use of an enteral tube for feeding use. The FDA released an safety communication in February, warning parents and healthcare professionals of the risk of strangulation when children are feeding tubes.

The warning came following two reports of deaths in 2021. Every time, a tube system was inadvertently wrapped around a baby under two years of age while they were not monitored by caregivers or hospital staff.

Avanos Medical "While FDA believes that death due to strangulation caused by enteral feeding set tubing for children is uncommon It is crucial that healthcare providers and caregivers are aware that events like this can and do happen," the FDA stated in its notice. Cortrak 2 eternal access system The FDA suggested that similar incidents might not yet have been reported.

Cortrak 2 eternal access system
Read More: https://www.igj.nl/binaries/igj/documenten/waarschuwingen/2022/05/11/avanos-medical-fca-2022-002---cortrak-2-enteral-access-system-eas/IT2061269+Avanos+FCA-2022-002+-+Cortrak+2+Enteral+Access+System+(EAS).pdf