Notes

Avanos Medical faces a Class I recall of its the feeding tube system linked to 23 deaths in 2015.

After seven years in which Avanos Medical's tube placement device was plagued with unlucky luck and a lack of trust, the FDA has issued its most severe instructions to recall the product.

Avanos Medical Avanos Medical feeding tube The Cortrak*2 Enteral Access System includes an electromagnetic stylet, an external receiver and an LCD monitor. When used together it provides an live stream of the positioning of a medical feeding tube into the stomach of a patient, or in the small bowel, with an aim of improving the accuracy of the tube's tip positioning and reducing complications.

Avanos was not satisfied with the mission and launched an recall of all Cortrak*2 units used between January 2021 & January 2022. The recall included approximately 630 units that were distributed between April 2016 and the start of this year.

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The safety incident is not an recall. Avanos doesn't ask healthcare providers send the devices back, but to ensure that they are using them in a safe manner.

A feeding tube that isn't correctly placed can result in severe injury or even death. Cortrak 2 eternal access system Avanos has reported 60 injuries and 23 deaths in 2015, the FDA stated. https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ All of these were connected to FDA's Cortrak*2 device used to insert the feeding tube.

The most common injuries are respiratory failure as well as collapsed lung, lung infection the pleural effusion and holes in the lung's walls, esophagus and bowel.

According to FDA in its March 21 field correction announcement, the Georgia-based company advised users to "confirm the placement of nasogastric and nasaloenteric pipes according to institution policies". Avanos Medical Avanos asked users to add the safety announcement to the operation manual of the system and verify with Avanos that the change was received.

Avanos announced that it will shortly release a new labeling system for the device, which will include the direction to determine the location of the tube in line with their facility's policies before making use of the system to assist install the tube.

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This is the second FDA warning this year about enteral feeding tubes. Avanos Medical Avanos Medical In February, the FDA published the safety announcement that warned parents and health professionals of the possibility of strangulation resulting from the use of feeding tubes for children.

Two deaths in 2021 were not reported in the announcement. In each case, a tubing system was discovered to accidentally wrap around the neck of a child under the age of two when they weren't directly watched by the medical staff or caregivers.

"While the FDA believes strangulation by enteral feeding tube tubing in children is not likely to result in injuries or death Healthcare providers and caregivers should be aware of this potential risk," the FDA stated 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 may not have been reported to the FDA.


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