Notes

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

The FDA has issued its most severe warning regarding the recall of Avanos Medical’s Enteral Feeding Tube Positioning System.

https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an exterior receiver, and a screen. When combined, the system gives a live stream of the medical tube as it is placed into the patient's stomach.

Avanos was not pleased with the mission and launched a recall of all Cortrak*2 units between January 2021 and January 2022. Avanos Medical feeding tube The recall covered nearly 630 devices that were distributed between April 2016 and the start of this year.

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

A feeding tube that is not properly installed can result in harm to vocal cords, or tracheas. https://www.medscape.com/viewarticle/891200 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its According to 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 and lung infections, collapsed lung as well as pleural effusion. holes in the lung's walls, esophagus and bowel.

According to FDA, in its March 21 Field Correction Notice, the Georgia-based business reminded users to "confirm the use of nasogastric (and the nasoenteric) tubes in accordance with institutional policy." Avanos has also asked them to attach the safety statement to the operating manual of the device and verify that they've received the latest update.

https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ Avanos has announced that they will shortly issue new labels to the device. Avanos Medical feeding tube These will include instructions on how to place a tube in line with their policies.

This is the FDA's third caution regarding the use of an enteral tube for feeding use. The FDA released a safety message in February that warned parents and healthcare professionals of the possibility of strangulation in children who feed tubes.

The notice followed two reports of death in 2021. Each case included a tube which was accidentally placed around the neck of a newborn under the age 2 while the child was not being observed by staff at the hospital.

"While FDA believes strangulation of children with enteral feeding set tubes in children is extremely rare caregivers and healthcare providers should be aware that these events could and do happen," the FDA said in the announcement. The FDA also suggested that the FDA might not have received reports of similar cases.


My Website: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding