Notes

Avanos Medical faces a Class I recall for its the feeding tube system that was linked to 23 deaths that occurred in 2015

The FDA has issued its most severe warning for the recall of Avanos Medical’s feed tube enteral positioning system.

Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also comes with a display monitor. In combination, the system gives an immediate stream of the medical tube as it is placed into the patient's stomach.

Avanos has announced the recall earlier in the month of all Cortrak*2 devices that were used between January 20,21 until January 20,22. The recall involved more than 630 devices.

The safety issue isn't a recall, in the strict sense. Avanos doesn’t ask healthcare providers to return the devices to the manufacturer. Cortrak 2 eternal access system Avanos wants them to utilize the devices properly.

Avanos Medical Cortrak 2 eternal access system A feeding tube that is not correctly inserted can cause grave injury or even death. Cortrak 2 eternal access system Avanos has reported more than 60 injury cases in 2015 as per the FDA. Avanos Mediacal Cortrak 2 Avanos Medical feeding tube Avanos Medical feeding tube This is all due to the FDA's Cortrak*2 system, which guides the placement of feeding tubes.

There are a variety of injuries that have been documented, including respiratory failure, lung infections and collapsed lung.

In its March 21 field correction notice, the Georgia-based company advised users to "confirm the placement of nasogastric as well as nasoenteric tubes according to the policies of the institution," per the FDA. Avanos asked users to add the safety announcement to the operating manual for the system and verify with Avanos that the update was received.

Avanos said it would shortly issue new labels to the device. They will contain instructions on how to place a tube in line the policies of Avanos.

This is the FDA's second warning regarding enteral feeding tube use. In February, the FDA released an safety announcement informing healthcare professionals and parents about the danger of strangulation when children are using feeding tubes.

The notice was issued as a result of two deaths that were reported in 2021. In each instance, a tubing system was discovered have inadvertently wrapped around the neck of a child who was less than two years old while they weren't being directly monitored by medical staff or caregivers.

Avanos Medical feeding tube "While the FDA believes that serious injury or death from strangulation with enteral feeding set tubing in children is rare Healthcare professionals and their caregivers must be aware that such events are possible and can happen," the agency said in the announcement and suggested that similar incidents may not had been reported to the FDA.


Website: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement