Notes

Avanos Medical faces Class I recall due to feeding tube system connection to 23 deaths.

After seven years during which Avanos Medical's intravenous tube placement device was struck with unfortunate luck and a lack of trust, the FDA handed out its most serious order for a recall.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an outside receiver and a display screen. Avanos Medical The system allows you to see the live position of a medical feeding tube inside a patient's stomach.

Avanos announced a recall earlier this month of every Cortrak*2 device that was used between January 20,21 until January 20,22. https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/ The recall affected nearly 630 devices.

The safety incident isn't a recall in its literal meaning: Avanos does not ask health professionals to return the devices back to the manufacturers. Instead, it would like to ensure that they're making use of the devices properly.

A feeding tube that is not properly installed can result in harm to vocal cords, or the tracheas. According to the FDA, Avanos received reports of 23 deaths and 60 injuries, as of 2015, all linked to the FDA's use of the Cortrak*2 system for guiding the installation of a feeding tube.

Avanos Medical These injuries could include respiratory failure, collapsed lungs, lung infection, as well as holes in the lung's walls and esophagus.

The FDA issued a march 21 field correction notice in which the Georgia-based firm reminded users to confirm the placement of nasogastric tubes as well as nasoenteric pipes according to institutional policies. Avanos has also asked users to attach the safety note to the operating manual for the device and to confirm that they have received the updated.

https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/ Avanos Medical Avanos said it will soon issue updated labeling for the device, which will include the direction to determine a tube's placement in accordance the policies of their facility prior to making use of the system to assist install the tube.

The FDA has issued a second caution in relation to tube feeding through the stomach. The FDA released a safety alert in February, advising healthcare professionals and parents of the potential for strangulation of children who use feeding tubes.

The warning came following two deaths were reported in 2021. In each case, a tubing system was found to be wrapped around the neck of a child under the age of two while they weren't being directly observed by their medical staff or caregivers.

"While the FDA believes that strangulation using feed set tubing for enteral feeding in children is uncommon healthcare professionals must be aware of these events," the agency stated in its notice. Avanos Medical feeding tube This suggests that similar instances may not have been reported to the FDA.


Here's my website: https://journals.lww.com/biomedicalsafetystandards/Citation/2022/07150/Avanos_Medical_Cortrak2_Enteral_Access_System.2.aspx