Notes

Avanos Medical is facing a Class I recall due to issues with the feeding tube system which have caused 23 deaths in the last year.

After seven years of unlucky luck for Avanos Medical's enteral feeding tube system The FDA has issued its most severe designation for recalls of the product.

Avanos Medical feeding tube Cortrak*2 Enteral Access System features an electromagnetic stylet with an external receiver and an LCD monitor. The system can be combined to provide a live feed that shows the process of inserting a medical feed tube into the stomach of a patient. This procedure is carried out to improve precision and reducing the risk of complications.

Avanos Medical Avanos was not happy with the results and announced an recall of all Cortrak*2 units used between January 2021 and January 2022. The recall covered nearly 630 devices that were distributed between April 2016 and the beginning of the year.

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The safety event is not an actual recall, but rather a sense: Avanos does not ask health professionals to return the devices to the manufacturer. Instead, it wants to ensure that they're using the devices properly.

Avanos Medical Incorrectly inserting the tube can result in harm to vocal cords and lungs. Avanos has reported the deaths of 23 people and 60 injuries cases since 2015 as per the FDA. This is all due to FDA's Cortrak*2 system that guides the placing feeding tubes.

Numerous injuries have been reported such as respiratory failure (collapsed lung) as well as lung infections and holes in the esophagus and walls.

The FDA has reminded patients that they need to confirm the that they have placed a nasogastric tube according to their institutional policies in its March 21 field correction notification. https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ Avanos has asked users to include a safety note in their operating manuals and verify they've updated their manuals.

Avanos has announced that they will soon release a updated labeling for its device. This will include directions for locating the position of a tube in accordance to the policies of their facility.

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The FDA has issued a second warning this year about enteral feeding tubes. In February, FDA released an safety alert warning parents and healthcare providers regarding the risk of strangulation among children using feeding tubes.

Avanos Medical This notice was issued as a result of two deaths reported in 2021. A tubing system was not monitored by staff or caregivers placed around the necks and necks of children under two years old.

"The FDA believes that strangulation by enteral feed set tubing in children is not common, however healthcare professionals and caregivers have be aware that such instances can occur and can occur," the agency stated in the notice. This suggests that similar instances may not have been reported to FDA.


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