Notes

Avanos Medical faces Class I recall because of the connection of the feeding tube system to 23 deaths.

After seven years during which Avanos Medical's enteral tube placement device was struck with unfortunate luck and mishaps, the FDA gave its most severe directive for a recall.

Cortrak*2 Enteral Access System features an electromagnetic stylet that includes an external receiver, a monitor for display and an electronic receiver. In combination, the system gives an immediate stream of the medical tube as it is placed into the stomach of the patient.

Avanos was not satisfied with the results and announced an recall of all Cortrak*2 units used between January 2021 and January 2022. The recall affected more than 630 units which were distributed between April 2016 and the beginning of the year.

The safety incident isn't a recall in the literal sense of the word: Avanos is not asking healthcare providers to send the devices back to the manufacturer instead, it's a way to make sure that they're using them correctly.

If a tube for feeding is not correctly placed, it could cause damage to the vocal cords, lungs or trachea which could result in grave injury or even death. Avanos Medical Avanos has reported the deaths of 23 people and 60 injuries cases in 2015 as per the FDA. This is all due to FDA's Cortrak*2 system, which guides placement of feeding tubes.

Avanos Medical feeding tube These injuries can include respiratory insufficiency, collapsed lungs, lung infection, and holes within the walls of the lungs and esophagus.

In the March 21 field correction notice, the Georgia-based company warned users to "confirm placement of nasogastric and nasoenteric tubes according to institutional policies," according to the FDA. Cortrak 2 eternal access system Avanos is advising users to add a safety warning to their operating manual and confirm that they have received the latest.

Avanos has indicated that it will soon issue new labeling for the device. It will also include the instructions for the location of a tube according to their facility's policies.

This is the second caution that the FDA has issued this year in relation to the use of enteral feeding tubes. The FDA published an entry-level safety alert in February alerting parents and healthcare professionals of the potential for strangulation of children who use feeding tubes.

The notice came after two deaths in 2021. In both instances the tubing device was found to be accidentally wrapped around neck of patient under 2 years old when they were not being monitored by their caregivers or hospital personnel.

Avanos Mediacal Cortrak 2 "While the FDA believes that strangulation caused by enteral feeding tube tubing in children is uncommon," the agency noted in its notice. http://b3.zcubes.com/v.aspx?mid=9231234 It suggested that other similar cases may not have been reported yet to the FDA.

Avanos Medical
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