Notes

Avanos Medical faces Class I recalls in connection to 23 deaths related to the feeding tube system.

After seven years in which Avanos Medical's enteral tube placement system was plagued with unlucky luck and a lack of trust, the FDA has given its most serious directive to issue a recall.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet, an external receiver and a monitor for display. When they are used together, the system offers an live stream of the positioning of the medical feeding tube in the stomach of a patient or into their small bowel, with the aim of improving the accuracy of the tube's tip positioning and reducing complications.

https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Avanos launched a recall earlier in the year for all Cortrak*2 devices that were used from January 2021 and January 2022. Cortrak 2 eternal access system This totaled nearly 630 devices. The devices were distributed in the first time from April 2016 to the beginning of the year.

RELATED
Promising greater safety, a tiny device can cause chaos to tube feeders
The safety event is not a reason to issue an recall. Avanos has asked healthcare providers not to return the devices back to the request of the manufacturer. But, they would like to make sure that they are making use of the devices.

Avanos Medical A tube for feeding that is not correctly inserted can cause serious injury or death. Avanos was informed of 23 deaths and 60 injuries in the year 2015 by the FDA. The incidents were all connected to the Cortrak*2 system that controls the placement of a feed tube.

There are several injuries that have been reported including respiratory failure, collapsed lung and lung infection.

According to FDA in its March 21 field correction notice, the Georgia-based firm advised users to "confirm placement nasogastric/nasoenteric pipes in accordance with the institution's policies". Avanos is also asking them to add the safety notice to the operating guideline of the system and confirm that they have received the update.

Avanos announced that it will shortly provide updated labels for the device, which will include the direction to map out a tube's placement in accordance with their facility's policies before using the system to help set up the tube.

Avanos Medical feeding tube RELATED
FDA issues an order requiring Philips to repair, replace, or exchange all recalled ventilators
The FDA has issued a second warning this year about enteral feeding tubes. The FDA issued a safety announcement in February that warned healthcare professionals and parents about the risk of strangulation in the event that children are feeding tubes.

This announcement was made due to two deaths that were reported in 2021. In each instance the tubing system was discovered accidentally wrap around the neck of a patient who was less than two years old while they weren't being directly observed by their caregivers or hospital workers.

"While the FDA believes strangulation by enteral feeding tube tubing in children is not likely to result in injuries or death Healthcare providers and caregivers should be aware of this possibility," the FDA stated in its notice. Cortrak 2 eternal access system It also noted that similar cases may not have been reported to the FDA.

Avanos Mediacal Cortrak 2
Website: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/