Notes

Avanos Medical faces Class I recalls due to feeding tube connection that led to 23 deaths.

The FDA has given its most severe warning in relation to the recall of Avanos Medical’s Enteral Feeding Tube Positioning System.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet with an external receiver as well as a monitor for display. Avanos Medical feeding tube Avanos Medical Together this system allows you to view the actual installation of a medical feed tube into the stomach of a patient.

Avanos announced a recall earlier this month of all Cortrak*2 device used between January 20,21 until January 20,22. The recall affected nearly 630 devices.

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The safety event is not recall in its true meaning: Avanos does not ask health professionals to return the devices to the manufacturer. Instead, it wants to ensure that they're using the devices correctly.

A feeding tube that isn't correctly placed can result in severe injury or death. Avanos has reported the deaths of 23 people and 60 injuries cases in 2015, according to FDA. This is all due to the FDA's Cortrak*2 system which directs the placing feeding tubes.

Avanos Mediacal Cortrak 2 The most common injuries are respiratory failure, lung infections, collapsed lung the pleural effusion and holes in the lungs' walls as well as the esophagus and bowel.

The FDA reminded users that they need to confirm the that they have placed a nasogastric tube according to their institutional guidelines in the March 21 field correction notice. Avanos has asked users to attach a safety notice to their operating manual and confirm they've updated their manuals.

Avanos said it will soon release a new labeling system for the device that will include a direction to determine the location of the tube in line the guidelines of their facility before making use of the system to assist set up the tube.

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This is the second FDA warning this year regarding tube feeding through the stomach. Avanos Medical feeding tube The FDA issued a safety communication in February that warned healthcare professionals and parents about the risk of strangulation in the event that children are using feeding tubes.

The announcement followed two instances of death in 2021. In both cases the tubing system was accidentally tied around the neck of a child when they weren't being closely monitored by the hospital staff or caregivers.

"While the FDA believes that strangulation from enteral feeding tube tubing in children is not likely to cause injuries or death, caregivers and healthcare providers should be aware of this potential risk," the FDA stated in the notice. The FDA also stated that similar cases may not have been reported to the FDA.

https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical
Read More: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement