Notes

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

After seven years of adversity for the Enteral Feeding Tube Placement System, the FDA has handed down its most severe designation for an immediate recall of the device.

Avanos Mediacal Cortrak 2 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 inserted into the stomachs of patients or small bowels. This facilitates an improvement in tip placement accuracy and the elimination of any complications.

https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement Avanos was not pleased with the results and announced a recall of all Cortrak*2 units used between January 2021 and January 2022. feeding tube placement The recall covered more than 630 units distributed in total between April 2016 & the start of this year.

The safety incident doesn't count as an recall in the strictest sense: Avanos doesn't ask healthcare professionals to have the device returned to the manufacturer. It's simply to make sure that they're using it correctly.

A tube for feeding that is not correctly inserted can cause grave injury or even death. Indeed, Avanos has received reports of 23 deaths and 60 injuries since 2015, the FDA declared, all of which were related to the the Cortrak*2 system to guide the placement of a feeding tube.

The most common injuries include respiratory failure, collapsed lung, lung infections, pleural effusion , and cracks in the wall, esophagus, bowel, and lungs.

The FDA issued a 21 March field correction notice in which the Georgia-based firm reminded users to verify the positioning of nasogastric tubes and nasoenteric pipes according to institutional policies. Cortrak 2 eternal access system Cortrak 2 eternal access system The company also asked users to attach the safety warning to the system's operating manual and to confirm with Avanos that they received the latest version of the notice.

Avanos announced that they will soon issue new labeling on the device. It will include the direction to place tubes according to their policies.

This marks the second warning the FDA has issued in the past year with regards to enteral feeding tubes. feeding tube placement The FDA issued the safety announcement in February warning healthcare professionals and parents about the dangers of strangulation in the event that children are feeding tubes.

Avanos Mediacal Cortrak 2 Two deaths occurred in 2021 and were disclosed in the announcement. Every time, a tubing system was inadvertently wrapped around a child who was less than two years of age while they were not observed by the hospital staff or caregivers.

"While the FDA believes that the risk of serious injury or death from strangulation with tubing for enteral feeding in children is rare Healthcare professionals and their caregivers need to be aware that these events could and do happen," the agency said in the notice warning that similar cases may not yet have been reported to the FDA.

feeding tube placement
Website: https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/