Notes

Avanos Medical faces a Class I recall of its feeding tube system connected to 23 deaths that occurred in 2015

Seven years after bad luck with Avanos Medical’s insertal feeding tube placement system for children, the FDA has issued its most serious warning regarding the recall of this device.

Cortrak*2 Enteral Access System has an electromagnetic stylet and an external receiver. It also has a display monitor. It can be combined to show a live stream which shows the process of inserting a feeding tube into the stomach of an individual. This procedure is carried out to improve accuracy and reducing complications.

Avanos issued the recall earlier in the month of every Cortrak*2 device that was in use between January 20,21 and January 20,22. The recall involved more than 630 devices.

The safety event isn't a recall in the literal sense of the word: Avanos is not asking health professionals to return the devices back to the manufacturer, but rather to ensure they're using the devices correctly.

Avanos Medical A feeding tube that is not properly placed can cause harm to vocal cords as well as the lungs. It can also result in grave injury or even death. Avanos recorded 60 injuries and 23 deaths in the last year, FDA stated. https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical All of them directly related to the FDA's Cortrak*2 device used to insert the feeding tube.

Avanos Mediacal Cortrak 2 Some of the injuries reported include respiratory failure, collapsed lung, lung infections, pleural effusion and holes in the walls and esophagus, bowel, and lungs.

According to FDA in its March 21 Field Correction Notice, Avanos, a Georgia-based company, reminded users to "confirm the placement of Nasogastric (and nasal) tubes in accordance with the institution's policy." They've also been asked to attach the safety notice to the operating manual for the system and to confirm with Avanos that they have received the latest version of the notice.

Avanos announced that it will shortly issue updated labeling for the device that will include a direction to plot a tube's placement in accordance with the guidelines of their facility before using the system to help install the tube.

https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ This is the FDA's third warning about enteral feeding tube use. In February, the agency released an safety message warning healthcare providers and parents of the possibility of strangulation in children who use feeding tubes.

The notice followed two reports of death in 2021. The notice followed two deaths in 2021. In each instance, the tubing system was found to be wrapped around the necks of patients under the age of 2.

Avanos Mediacal Cortrak 2 "While the FDA considers strangulation caused by enteral feed set tubing in children is uncommon healthcare professionals must be aware of such incidents," the agency stated in its notice. Cortrak 2 eternal access system This suggests that similar cases could not have been reported to the FDA.


Read More: https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/