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Avanos Medical faces Class I recalls for its the feeding tube system that has been associated with 23 deaths since 2015.

After seven years of poor results with the Avanos Medical Insertal tube feeding system for children The FDA has issued its most serious warning about the recall of this device.

Avanos Medical Cortrak*2 Enteral Access System features an electromagnetic stylet that includes an external receiver, a display monitor as well as an electronic receiver. When they are used together the system provides an live stream of the process of inserting the medical feeding tube in the stomach of a patient, or in the small bowel, with an intention of improving the accuracy of the tube's tip positioning and reducing complications.

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

The safety incident isn't a recall in the literal sense: Avanos is not asking health professionals to return the device back to its manufacturer, instead, they want to make sure they're using them in a safe manner.

A feeding tube that is not properly placed can damage vocal cords and the lungs. It could also cause serious injury or even death. Avanos Medical Indeed, Avanos has received reports of 23 deaths and 60 injuries since the year 2015 according to the FDA stated, all of which were connected to the use of the Cortrak*2 system to guide the installation of a feeding tube.

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

Avanos Mediacal Cortrak 2 The FDA issued a March 21 field correction notification in which the Georgia-based firm urged users to verify the positioning of nasogastric tube and nasoenteric pipes according to institutional guidelines. Avanos Medical feeding tube placement Avanos is also asking them to attach the safety statement to the operating guideline of the system and confirm that they have received the updated.

Avanos announced that it will shortly release a new labeling system for the device, which will include the direction to determine the tube's location in accordance with their facility's policies before using the system to help set up the tube.

The FDA has issued a second warning on tube feeding into the gastrointestinal tract this year. In February, the agency released a safety communication informing healthcare professionals and parents of the possibility of strangulation when children are using feeding tubes.

The announcement came in the wake of two reports of death in 2021. In each case, a tubing system was discovered to be wrapped around the neck of a patient younger than 2 when they weren't directly monitored by medical staff or caregivers.

"While the FDA believes that strangulation caused by enteral feeding tube tubing in children is uncommon," the agency noted in the notice. https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns It also suggested that similar cases might not have been reported yet to the FDA.

feeding tube placement
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