Notes

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

The FDA has issued the most extreme warning for the recall of Avanos Medical’s enteral feeding tube positioning system.

Cortrak*2 Enteral Access System features an electromagnetic stylet with an external receiver, a display monitor and an electronic receiver. https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/ https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas In combination with the display monitor, the system provides a live stream of the medical feeding tube as it is placed into the stomach of the patient.

https://www.medicalbuyer.co.in/fda-identifies-avanos-medicals-cortrak-2-eas-recall-as-class-i/ Avanos launched a recall earlier in the year for all Cortrak*2 devices that were used from January 2021 and January 2022. The total number of affected devices was 630. devices, which was first distributed between April 2016 and the beginning of the year.

Avanos Medical feeding tube Avanos Medical feeding tube The safety incident isn't a recall in the literal sense: Avanos is not asking healthcare professionals to send the devices back to the manufacturer but rather to ensure they're using them correctly.

A feeding tube that is not correctly inserted can cause serious injury and even cause death. Avanos was informed of the deaths of 23 people and injuries to 60 in 2015 by the FDA. The incidents were all linked to the Cortrak*2 system that guides the positioning of the feeding tube.

There are a variety of injuries that have been documented such as respiratory failure, lung infection and collapsed lung.

https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its The FDA issued a march 21 field correction notice that the Georgia-based firm reminded users to verify the location of nasogastric tubes and nasoenteric pipes according to institutional guidelines. Avanos asked users to include the safety notice in the system's operation manual and confirm with Avanos that the update was received.

Avanos announced that they would soon issue new labeling on the device. Cortrak 2 eternal access system The label will contain the directions to put tubes according to their policies.

This is the FDA's third warning about enteral feeding tube use. The FDA issued an entry-level safety announcement in February alerting parents and healthcare professionals of the potential for strangulation of children who feed tubes.

In the wake of two deaths in 2021 a notice was issued. The notice followed two reports of death in 2021. Avanos Medical feeding tube In each case the tubing system was discovered to be wrapped around the necks of patients who were under the age of 2.

Avanos Medical feeding tube "While the FDA believes that serious injury or death caused by strangulation from tubing for enteral feeding for children is extremely rare Healthcare professionals and their caregivers need to be aware of the fact that such incidents can and do occur," the agency said in the notice, suggesting that other similar incidents may not have been reported to the FDA.


Read More: https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas