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 unlucky luck for the feed tube inserter, the FDA has handed down its most serious designation for the recall of the device.

Avanos Mediacal Cortrak 2 The Cortrak*2 Enteral Access System includes an electromagnetic stylet, an external receiver and a display monitor. It can be used in conjunction to provide a live feed that illustrates the process of inserting a medical feeding tube into the stomach of the patient. This procedure is carried out in the hope of increasing the accuracy of the procedure and decreasing complications.

Avanos announced an earlier year to all Cortrak*2 devices which were in use between January 2021 to January 2022. This totaled nearly 630 devices. The devices were first distributed from April 2016 until the beginning of 2016.

The incident that caused the safety issue isn't a recall in any strict sense: Avanos does not ask healthcare providers for the device to be returned to the maker. It's just to make sure that they're using it correctly.

A tube for feeding that is not properly inserted could cause serious injuries or even death. Avanos Mediacal Cortrak 2 According to the FDA, Avanos received reports of 23 deaths and 60 injuries, as of 2015, all related to FDA's use of the Cortrak*2 system for guiding the installation of a feeding tube.

Avanos Medical A few of the injuries that have been reported include respiratory failure, collapsed lung, lung infections, pleural effusion and holes in the walls and esophagus, bowel, and lungs.

Cortrak 2 eternal access system In its March 21 field correction notice, the Georgia-based company advised users to "confirm the use of nasogastric or Nasoenteric tubes as per the policies of the institution," as per the FDA. Avanos is advising users to attach a safety notice to their operating manual and to confirm they have received the updated.

Avanos announced that it will soon issue new labeling guidelines for its device. This will include directions for locating the position of a tube in accordance to the guidelines of their facility.

This is the second FDA warning of the year for tube feeding through the stomach. The FDA released safety communication in February warning parents, healthcare professionals, and children about the dangers of strangulation through tubes for feeding.

This announcement was made due to two deaths that were reported in 2021. https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 In both instances, a tubing device was discovered to be accidentally wrapped around neck of patient under 2 years old when they were not supervised by caregivers or hospital workers.

Avanos Medical feeding tube "While the FDA considers strangulation caused by feed set tubing for enteral feeding in children is uncommon Healthcare professionals should be aware of these events," the agency stated in the notice. Avanos Medical feeding tube This suggests that similar cases might not have been reported to the FDA.


Website: https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical