Notes

Avanos Medical is facing a Class I recall due to feeding tube system malfunctions that have caused 23 deaths since the year 2015.

After seven years of failure for Avanos Medical, Avanos Medical’s Enteral Feeding Tube Placing System has been recalled by the FDA has issued the most serious recall notice ever issued.

Avanos Medical feeding tube Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also comes with an LCD monitor. In combination this system allows you to view the live placing of a medical feeding tube into the stomach of a patient.

Avanos Medical Avanos initiated the recall earlier this year of all Cortrak*2 equipment in use between Jan 2021 and Jan 2022. There were more than 630 devices initially distributed between April 2016 to the beginning.

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The safety event isn't an actual recall, but rather a sense: Avanos does not ask health professionals to return the devices back to the manufacturers. Instead, it wants to make sure they're using the devices correctly.

If a feeding tube is incorrectly inserted it could cause damage to the vocal cords, lungs, or trachea and cause severe injury or death. According to FDA, Avanos received reports of 23 deaths, and 60 injuries, as of 2015, all of which were related to the FDA's usage of the Cortrak*2 system for guiding the placement of the feeding tube.

There are several injuries which have been reported including respiratory failure, collapsed lung and lung infection.

According to the FDA, the Georgia-based company issued a March 21 field correction note that reminded users to confirm the placement of nasogastric tubes as well as tubs for nasoenteric according to the institution's policies. Avanos requested that users attach the safety notification to the operation manual of the system and then confirm that they have notified Avanos that the change was accepted.

Avanos announced that it will soon release a updated labeling for its product. https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns This will include directions to map the placement of the tube in line to their policies for their facility.

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The FDA has issued a second warning about the use of enteral feeding tubes this year. In February, the agency put out a safety communication informing healthcare professionals and parents of the possibility of strangulation when children use feeding tubes.

This announcement was made due to two deaths reported in 2021. https://www.hcplive.com/view/fda-issues-letter-to-health-care-providers-about-pneumothorax-events In both cases the tubing system was accidentally tied around the neck of a child while they were not being closely observed by the hospital staff or caregivers.

"While the FDA considers that strangulation caused by tubes for feeding tubes in the gastrointestinal tract of children is not likely to result in fatal injury or death, caregivers and healthcare providers should be aware of the possibility," the FDA stated in its notice. The FDA also stated that similar incidents could not have been reported to the FDA.


Here's my website: https://www.medscape.com/viewarticle/891200