Notes

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

After seven years' of failure for Avanos Medical’s Enteral Feeding Tube Placing System Avanos Medical's Enteral Feeding Tube Placement System has failed for FDA has designated the most serious class for recalls.

Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also comes with a display monitor. When used together with the display monitor, the system provides live streaming of the medical feeding tube as it is placed into the patient's stomach.

Despite this goal, it has been implicated in dozens of patient injuries, leading Avanos to issue an recall in January of all Cortrak*2 devices used between January 2021 and January 2022--totaling nearly 630 devices first released between April 2016 until the beginning of this year.

The safety incident isn’t recall in the literal sense. Avanos Medical Avanos Medical feeding tube Avanos doesn’t ask healthcare providers send the devices back at the factory. Avanos wants them to make use of the devices in a safe manner.

If a tube for feeding is incorrectly inserted, it can damage the vocal cords, lungs or trachea and cause severe injury or even death. 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 Avanos was informed of 23 deaths and 60 injuries in 2015 by the FDA. https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns These incidents were all connected to the Cortrak*2 system that guides the positioning of the feeding tube.

A variety of injuries have been reported including respiratory failure (collapsed lung) as well as lung infections, pleural effusion, gaps in the walls, the esophagus and bowel.

According to FDA in the March 21 Field Correction Notice Avanos, a Georgia-based company, reminded users to "confirm the placement of the nasogastric (and the nasoenteric) tubes according to institutional policy." Avanos is advising users to include a safety note in their operating manuals and verify that they have received the latest.

Avanos indicated that it will soon release updated labels to the device. These will include the instructions for where to place the tube in line to their guidelines.

This is the FDA's second caution in relation to tube feeding through the stomach. feeding tube placement The FDA released safety announcement in February, warning parents, healthcare professionals, and children about the dangers of strangulation through tubes for feeding.

Following two deaths in 2021, the notification was issued. Every time, a tubing system was inadvertently wrapped around a child under two years old, even though they were not observed by hospital staff or caregivers.

"While the FDA believes strangulation with enteral feed set tubing in children is not common healthcare professionals must be aware of such incidents," the agency stated in the notice. This suggests that similar instances may not have been reported to the FDA.


Website: 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