Notes

Avanos Medical is facing a Class I recall due to problems with the feeding tube system that have resulted in 23 deaths in the last year.

The FDA has issued its most severe warning regarding the recall of Avanos Medical’s Enteral Feeding Tube Positioning System.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an exterior receiver, and a screen. It can be utilized in conjunction with the system to stream a live video that illustrates the process of inserting a medical feed tube into the stomach of an individual. This is done in the hope of increasing precision and reducing the risk of complications.

Despite this task, the system has been implicated in dozens of patient injuries, leading Avanos to issue an recall earlier in the year of all Cortrak*2 devices between January 2021 to January 2022. This totals more than 630 devices that were distributed between April 2016 until the beginning of this year.

The safety incident doesn't count as a recall in the strictest sense: Avanos doesn't ask healthcare professionals to request that the device be returned to the maker. It's merely to ensure that they're using the device in a safe manner.

A feeding tube that is not properly installed can cause damage to vocal cords or tracheas. Avanos Medical Indeed, Avanos has received reports of 23 deaths and 60 injuries since the year 2015, the FDA declared that all of them were connected to the use of the Cortrak*2 system that guides the placement of a feeding tube.

There are a variety of injuries reported such as respiratory failure, lung infections and collapsed lung.

The FDA has reminded patients that they need to confirm the that they have placed a nasogastric tube according to their institutional policies in its March 21 field correction notice. https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement/ They've also been instructed to attach the safety warning to the operating manual for the system and to confirm with Avanos that they've received the updated.

Avanos has announced that they will soon issue a new label for the device. This will include directions for locating the tube in accordance with their policies for facilities.

https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges The FDA has issued a second warning regarding the use of enteral feeding tubes this year. The FDA released the safety announcement in February that warned healthcare professionals and parents about the danger of strangulation if children are using tubes for feeding.

Two deaths occurred in 2021 and were reported in the announcement. Cortrak 2 eternal access system The notice was issued following two reports of death in 2021. Avanos Medical feeding tube In each case the tubing system was found to have been wrapped around the necks of patients who were under the age of 2.

"While the FDA believes that strangulation by tube feeding into the enteral system in children is not common," the agency noted in its notice. It suggested that other similar cases may not have been reported to the FDA.


Here's my website: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause?utm_medium=email&utm_source=govdelivery