Notes

Avanos Medical is facing a Class I recall due to issues with the feeding tube system which have led to the deaths of 23 patients since 2015.

The FDA has given the most extreme warning in relation to the recall of Avanos Medical's enteral feeding tube positioning system.

Cortrak*2 Enteral Access System contains an electromagnetic stylet as well as an external receiver. The system gives a live stream of medical tube feeding being placed into patients' stomachs or small bowels. This facilitates an improvement in tip placement accuracy as well as the reduction of complications.

Avanos initiated an earlier this year for all Cortrak*2 equipment in use between Jan 2021 to Jan 2022. There were nearly 630 devices originally distributed between April 2016 to the beginning.

The safety incident doesn't count as an recall in the strictest sense. Avanos does not ask healthcare providers to have the device returned to the maker. It's just to make sure that they're using the device in a safe manner.

If a tube for feeding is not correctly placed, it could cause damage to the vocal cords, lungs or the trachea and cause serious injury or death. According to the FDA, Avanos received reports of 23 deaths and 60 injuries, since 2015, all of which were related to FDA's use of the Cortrak*2 system for guiding the placement of a feeding tub.

The reported injuries include respiratory failure, lung infections, collapsed lung the pleural effusion and holes in the lungs' walls as well as the esophagus and bowel.

According to the FDA, the Georgia-based company issued users a March 21 field correct note to "confirm the use of tubs in nasogastric/nasoente to the institution's policies". Avanos Medical The company also asked users to attach the safety warning to the operating manual of the system and verify with Avanos that they've received the latest version of the notice.

Avanos has announced that they will soon issue a new label for the device. It will also include the direction for locating a tube according to their facility's policies.

Cortrak 2 eternal access system This is the second caution that the FDA has issued in the past year with regards to enteral feeding tubes. Avanos Medical The FDA released an entry-level safety alert in February alerting parents and healthcare professionals of the risk of strangulation for children who use feeding tubes.

This notice was issued as a result of two deaths that were reported in 2021. In both cases, a tubing device was discovered to have been inadvertently wrapped around necks of patients who were less than 2 years old while they were not supervised by hospital staff or caregivers.

Avanos Medical "While the FDA believes that serious injury or death due to strangulation caused by enteral feeding set tubing for children is extremely rare, healthcare providers and their caregivers must be aware of the fact that such incidents can and do occur," the agency said in the notice and suggested that similar cases might not have been reported to the FDA.

Avanos Medical
Website: https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/