Notes

Avanos Medical faces Class I recalls in relation to 23 deaths related to the tube feeding system.

After seven years during which Avanos Medical's intravenous tube placement system was plagued with unfortunate luck and mishaps, the FDA has given its most serious directive for a recall.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an external receiver, and a display monitor. The system is able to be combined to provide a live feed that shows the procedure of inserting a feeding tube in the stomach of the patient. The procedure is performed to improve the accuracy of the procedure and decreasing complications.

Avanos Medical Avanos initiated an earlier this year, involving every Cortrak*2 piece of equipment that was that was used between January 2021 to Jan 2022. There were nearly 630 devices originally distributed between April 2016 through the beginning.

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The incident that caused the safety issue isn't a recall in any strict sense. Avanos doesn't ask healthcare professionals for the device to be returned back to the manufacturer. It's merely to ensure that they're using it correctly.

Avanos Medical Incorrectly inserting a feeding tube can cause damage to the vocal cords, lungs or the trachea. This can lead to serious injuries, or death. Avanos was notified of 23 deaths and 60 injuries in the year 2015 by the FDA. These events were all related to the Cortrak*2 system that controls the positioning of a feed tube.

The injuries reported include respiratory failure and collapsed lung, lung infection, pleural effusion, and holes in the lungs' walls or esophagus, as well as the bowel.

The FDA has reminded patients of the need to verify the placement of a nasogastric or nasoente tube in accordance with their institution policies in its March 21 field correction notification. Avanos advised that patients attach the safety notice and verify with Avanos they received the updated.

Avanos has indicated that it will soon issue new labeling for its device. The labeling will be able to include the direction to map a tube's location in accordance the policies of their facility.

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This is the FDA’s second warning in relation to enteral-feeding tubes. In February, the FDA released a safety announcement informing parents as well as healthcare professionals of the dangers of strangulation resulting from the use of feeding tubes for children.

Avanos Medical This announcement was made as a result of two deaths in 2021. Avanos Medical feeding tube The notice followed two reports of death in 2021. Avanos Mediacal Cortrak 2 In both instances, the tubing system was discovered to be placed around necks of patients who were under the age 2.

"While the FDA believes that serious injury or death from strangulation with tubing for feeding through the enteral system in children is rare Healthcare providers and caregivers should be aware of the fact that these incidents are possible and can happen," the agency said in the announcement warning that similar cases may not yet had been reported to the FDA.


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