Notes

Avanos Medical faces Class I recalls in connection to 23 deaths related to the tube feeding system.

Seven years after adversity for Avanos Medical's feed tube placement system The FDA has given its most severe designation for recalls of the product.

Cortrak*2 Enteral Access System contains an electronic stylet and an external receiver. When they are used together it provides a live feed of the process of inserting a medical feeding tube into the stomach of a patient, or in the small bowel, with the goal of improving the precision of the tube's placement and reducing the risk of complications.

Avanos issued a recall earlier in the year, affecting all Cortrak*2 units that were used between January 2021 and January 2022. The total number of affected devices was 630. devices, which was distributed in the first time from April 2016 and the beginning of the year.

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The safety incident is not a recall. Avanos doesn't ask healthcare providers send the devices back however, it is a way to ensure they use them correctly.

Avanos Medical feeding tube If a feeding tube is placed incorrectly, it can damage the vocal cords, lungs or trachea which could result in grave injury or even death. Avanos was informed of more than 60 injuries and 23 deaths in the year 2015 by the FDA. These events were all related to the Cortrak*2 system that guides the position of a feed tube.

Cortrak 2 eternal access system The most common injuries include respiratory failure and collapsed lung as well as lung infections. holes in the walls of the esophagus and the lungs.

According to FDA in its March 21 field correction notice, the Georgia-based firm warned users to "confirm the installation of nasogastric/nasoenteric pipe according to the policies of the institution". Avanos is also asking them to add the note on safety to the operating manual for the device and to confirm that they've received the update.

Avanos announced that they will soon issue an updated labeling for the device. It will include the directions to put a tube according to their guidelines.

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The FDA has issued a second warning regarding enteral feeding tubes this year. Avanos Medical feeding tube In February, the FDA issued a safety communication that warned parents and healthcare professionals of the dangers of strangulation resulting from the usage of tubes for feeding by children.

Following two death reports in 2021, this notice was issued. In both instances, a tubing system was accidentally tied around the neck of a child while they were not being closely monitored by hospital staff or caregivers.

Avanos Medical feeding tube "While the FDA believes that serious injury or death from strangulation with enteral feeding set tubing in children is uncommon, healthcare providers and caregivers should be aware that these events can and do occur," the agency said in its notice, suggesting that other similar incidents may not have been reported to the FDA.


Homepage: https://avanos.com/investor-news/response-to-inquiries-about-the-avanos-cortrak-2-voluntary-field-correction/