Notes

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

The FDA has issued the most extreme warning in relation to the recall of Avanos Medical’s feed tube enteral positioning system.

https://journals.lww.com/biomedicalsafetystandards/Citation/2022/07150/Avanos_Medical_Cortrak2_Enteral_Access_System.2.aspx Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also includes a monitor for display. It provides a continuous stream of medical tube feeding that are inserted in patients' stomachs or small bowels. This allows for the improvement of tip placement accuracy and the reduction of complications.

Avanos was not happy with its mission and launched a recall of all Cortrak*2 units between January 2021 and January 2022. The recall affected more than 630 units that were distributed between April 2016 and the beginning this year.

The safety incident isn't a recall in the literal sense: Avanos is not asking healthcare providers to send the devices back to the manufacturer but rather to ensure they're using the devices correctly.

The incorrect placement of a feeding tube could result in damage to the vocal cords, lungs or trachea. This could result in serious injury, or even death. Avanos has reported the deaths of 23 people and 60 injuries cases since 2015 as per the FDA. Avanos Medical This was all due to FDA's Cortrak*2 system, which directs the placement of feeding tubes.

Many different injuries have been reported including respiratory failure (collapsed lung), lung infection as well as pleural effusions, holes in the walls, esophagus, and bowel.

Avanos Medical feeding tube In its March 21 field correction note, the Georgia-based business warned users to "confirm placement of nasogastric and Nasoenteric tubes as per guidelines of the institution" per the FDA. Cortrak 2 eternal access system Avanos asked that patients attach the safety notice and confirm with Avanos that they've been up-to-date.

https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf Avanos has announced that they will soon issue a new label for the product. It will also include the direction for locating a tube according their facility policies.

This is the FDA's second warning of the year for the use of enteral feeding tubes. Cortrak 2 eternal access system https://www.nutritioncare.org/News/General_News/Nasoenteric_Feeding_Tube_Placement_and_Verification/ Avanos Medical feeding tube In February, the agency released an safety announcement to inform healthcare professionals and parents of the possibility of strangulation when children are using feeding tubes.

The announcement came in the wake of two deaths were reported in 2021. Every time, a tubing system was inadvertently wrapped around a child under two years of age while they were not being closely observed by hospital staff or caregivers.

"While FDA believes strangulation of children with enteral feeding tubes in children is extremely rare caregivers and healthcare professionals should be aware that these events could and do occur," the FDA said in the announcement. They also said that the FDA has not yet received reports of similar cases.


Read More: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement/