Notes

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

After seven years during which Avanos Medical's enteral tube placement device was struck with unfortunate luck and a lack of trust, the FDA gave its most serious directive to recall the product.

https://avanos.com/investor-news/response-to-inquiries-about-the-avanos-cortrak-2-voluntary-field-correction/ Cortrak*2 Enteral Access System contains an electronic stylet, as well as an external receiver. It provides a continuous stream of medical tube feeding that are inserted into the stomachs of patients or small bowels. This facilitates an improvement in tip placement accuracy as well as the reduction of complications.

Despite that mission, however, the system has been implicated in dozens of patient injuries, leading Avanos to issue a recall earlier this year of all Cortrak*2 units used between January 2021 and January 2022, totalling nearly 630 devices first released between April 2016 until the beginning of the year.

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

A feeding tube that is not properly placed can cause damage to the vocal cords, lungs, or the trachea. Cortrak 2 eternal access system This could lead to severe injury or death. Avanos has reported more than 23 deaths and 60 injuries in 2015, the FDA said. All of them were directly related to FDA's Cortrak*2 device used to insert a feeding tube.

There are many injuries reported, including respiratory failure, lung infection and collapsed lung.

The FDA issued a 21 March field correction notice in which the Georgia-based company reminded users to verify the positioning of nasogastric tubes and Nasoenteric pipes in accordance with institutional guidelines. Avanos Medical Avanos is advising users to attach a safety notice to their operating manual and confirm they've received the new.

Avanos has stated that it will shortly issue new labels for the device. https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system It will also include the direction for locating a tube according to their facility's policies.

This is the second warning that the FDA has issued this year with regard to enteral feeding tubes. The FDA released the safety message in February, warning parents and healthcare professionals of the danger of strangulation if children are feeding tubes.

This notice was issued in response to two deaths that were reported in 2021. Cortrak 2 eternal access system In both instances, a tubing device was found to be accidentally wrapped around neck of patient under 2 years old while they were not being watched by hospital staff or caregivers.

"While the FDA believes that the risk of serious injury or death due to strangulation caused by enteral feeding set tubing in children is uncommon Healthcare providers and caregivers should be aware that these events can and do occur," the agency said in the notice and suggested that similar cases may not yet had been reported to the FDA.


Read More: https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system