Notes

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

After seven years of bad experience with Avanos Medical's insertal feeding tube placement system for children, the FDA has issued the most severe warning about the recall of this device.

Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also has a display monitor. The system can be combined to provide a live feed which shows the process of inserting a medical feed tube into the stomach of the patient. The procedure is performed with the aim of improving precision and reducing the risk of complications.

feeding tube placement Avanos launched an earlier year, affecting all Cortrak*2 units that were used from January 2021 and January 2022. feeding tube placement It was nearly 630 devices. They were first distributed between April 2016 to the beginning of 2016.

The safety incident doesn't count as a recall in any strict sense. Avanos doesn't ask healthcare professionals for the device to be returned to the maker. Avanos Mediacal Cortrak 2 It's just to make sure that they're properly using them.

A feeding tube that is not properly placed can cause harm to vocal cords as well as lungs. It can also result in grave injury or even death. Indeed, Avanos has received reports of 23 deaths and 60 injuries since 2015 The FDA declared all of which were connected to the use of the Cortrak*2 system to guide the placement of the feeding tube.

Avanos Mediacal Cortrak 2 These injuries can include respiratory failure, collapsed lungs, lung infection, and holes in the walls of the lungs and the esophagus.

The FDA advised users that they need to confirm the placement of nasogastric or nasoenteric tube in accordance with their institution policies in the March 21 field correction notification. Avanos requested that users include the safety notice in the operation manual of the system and confirm that they have notified Avanos that the update was approved.

Avanos indicated that it will shortly issue new labels for the device. These will include instructions on where to place the tube in line with their policies.

The FDA has issued a second caution regarding the use of an enteral tube for feeding use. Avanos Medical feeding tube The FDA issued an entry-level safety message in February, advising healthcare professionals and parents of the risk of strangulation for children who are fed through tubes.

This announcement was made in response to two deaths in 2021. Every time, a tube system was inadvertently wrapped around a child under two years old while they were not being closely observed by the hospital staff or caregivers.

"While the FDA believes that strangulation using enteral feed set tubing in children is rare Healthcare professionals should be aware of the possibility of this happening," the agency stated in the announcement. Avanos Medical feeding tube This suggests that similar instances might not have been reported to FDA.


Read More: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/