Notes

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

After seven years of bad luck with Avanos Medical’s insertal feeding tube placement system for children The FDA has issued the most severe warning regarding the recall of the device.

Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also has an LCD monitor. https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ The system can be used in conjunction to show a live stream that shows the procedure of inserting a medical feed tube into the stomach of a patient. This is done to improve the accuracy of the procedure and decreasing complications.

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

The safety incident does not mean that there is an recall. Avanos has asked healthcare providers not to send the devices back to the manufacturer. https://medicaldevices.icij.org/devices/hkg-cortrak-2-enteral-access-system-eas Avanos only wants to make sure that the devices are being properly used.

Avanos Medical feeding tube A feeding tube installed incorrectly can result in damage to vocal cords or tracheas. Avanos has reported 23 deaths and 60 injury cases since 2015 as per the FDA. This is all because of the FDA's Cortrak*2 system, which guides placement of feeding tubes.

Numerous injuries have been described, including respiratory failure (collapsed lung) lung infection, pleural effusion, holes in the walls, esophagus and bowel.

https://www.igj.nl/binaries/igj/documenten/waarschuwingen/2022/05/11/avanos-medical-fca-2022-002---cortrak-2-enteral-access-system-eas/IT2061269+Avanos+FCA-2022-002+-+Cortrak+2+Enteral+Access+System+(EAS).pdf The FDA issued a march 21 field correction notice in which the Georgia-based company reminded users to verify the positioning of nasogastric tubes as well as nasoenteric pipes according to institutional policies. Avanos is advising users to include a safety note in their operating manual and to confirm they've received the new.

Avanos announced that it will shortly release a new labeling system for the device. It will contain the directions to plot the location of the tube in line with the guidelines of their facility before using the system to help set up the tube.

This marks the second warning the FDA has issued this year in relation to enteral feeding tubes. Cortrak 2 eternal access system The FDA issued an safety announcement in February that warned parents and healthcare professionals of the dangers of strangulation in the event that children are tubes for feeding.

Two deaths occurred in 2021 and were reported in the announcement. Each time, a tubing system was inadvertently wrapped around a baby under two years old while they were not being closely watched by caregivers or hospital staff.

"While the FDA believes strangulation with enteral feed set tubing in children is rare healthcare professionals must be aware of the possibility of this happening," the agency stated in its notice. This suggests that similar cases may not have been reported to the FDA.


Read More: https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/