Notes

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

Seven years after unlucky luck for the Avanos Medical enteral feeding tube placement system The FDA has issued the most serious of designations for recalls of the product.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an outside receiver with a display monitor. It provides a continuous feed of medical feeding tubes that are inserted in patients' stomachs or small bowels. This permits the improvement of tip placement accuracy and the elimination of any complications.

Cortrak 2 eternal access system In spite of that task it has been implicated in numerous injuries to patients which led Avanos to issue a recall earlier this year of all Cortrak*2 devices used between January 2021 and January 2022--totaling nearly 630 devices first distributed between April 2016 and the start of this year.

RELATED
A tiny gadget can create chaos for tube feeders
The incident that caused the safety issue is not a reason to issue the occurrence of a recall. Avanos has asked healthcare providers to not send the devices back to the request of the manufacturer. However, they want to ensure they are correctly making use of the devices.

The incorrect placement of a feeding tube could cause injury to the vocal cords, lungs, or the trachea. Avanos Mediacal Cortrak 2 This could result in serious injury, or even death. Avanos Mediacal Cortrak 2 In actual fact, Avanos has received reports of 23 deaths and 60 injuries since 2015, the FDA declared that all of them were related to the use of the Cortrak*2 system that guides the placement of a feeding tube.

There are several injuries which have been reported including respiratory failure, collapsed lung, lung infections.

https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html The FDA has reminded patients that they must confirm placement of nasogastric or nasoenteric tube in accordance with their institution policies in the March 21 field correction notification. Avanos requested that users add the safety announcement to the operation manual of the system and confirm that they have notified Avanos that the change was approved.

Avanos stated that it will shortly issue a revised labeling for its product. Cortrak 2 eternal access system Cortrak 2 eternal access system It will also include instructions to indicate the location of the tube according to their facility's policies.

RELATED
FDA issue an order requiring Philips to fix, replace, or exchange all recalled ventilators
This is the FDA’s second warning on the use of enteral feeding tubes this year. In February, the FDA issued a safety alert informing parents and healthcare professionals about the potential for strangulation in children who use feeding tubes.

Two deaths occurred in 2021 and were disclosed in the announcement. The notice followed two reports of deaths in 2021. In each instance, the tubing system was found to have been tied around necks of patients under the age of 2.

"While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is uncommon healthcare professionals and caregivers should be aware that these events are possible and can happen," the agency said in the notice warning that similar incidents may not have been reported to the FDA.


My Website: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement