Notes

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

After seven years of bad luck for Avanos Medical's enteral feeding tube placement system Avanos Medical's enteral feeding tube placement system, the FDA has given its most severe designation for a recall of the device.

Cortrak*2 Enteral Access System features an electromagnetic stylet, which includes an external receiver, a display monitor as well as an electronic receiver. It provides a continuous feed of medical feeding tubes being inserted into the stomachs of patients or small bowels. This permits the improvement of tip placement accuracy as well as the elimination of any complications.

In spite of that goal however, the system has been implicated in dozens of injuries to patients, causing Avanos to announce an recall earlier in the year of all Cortrak*2 units used between January 2021 and January 2022, totalling nearly 630 devices first distributed between April 2016 and the beginning of this year.

The safety event is not a recall in its literal meaning: Avanos does not ask healthcare providers to return the devices to the manufacturer. Instead, it wants to ensure that users are making use of the devices properly.

If a feeding tube is incorrectly inserted, it can harm the vocal cords, lungs, or trachea which could result in serious injury or death. feeding tube placement According to the FDA, Avanos received reports of 23 deaths and 60 injuries, since 2015, all of which were related to FDA's usage of the Cortrak*2 system for guiding the placement of a feeding tub.

Avanos Mediacal Cortrak 2 There are several injuries that have been reported which include respiratory failure, lung infection and collapsed lung.

According to FDA in the March 21 Field Correction Notice Avanos, a Georgia-based company, advised users to "confirm the use of the nasogastric (and nasal) tubes in accordance with institutional policy." Avanos Medical Cortrak 2 eternal access system They've also been asked to attach the safety warning to the operating manual of the system and to confirm with Avanos that they've received the latest version of the notice.

Avanos announced that they'll soon release new labeling on the device. Avanos Mediacal Cortrak 2 The label will contain the direction to place tubes according to their policies.

This is the FDA’s second warning in relation to enteral-feeding tubes. The FDA issued a safety announcement in February that warned healthcare professionals and parents about the risk of strangulation for children who feed tubes.

The announcement came in the wake of two deaths reported in 2021. Every time, a tube system was wrapped around a baby under two years of age while they were not being closely observed by the hospital staff or caregivers.

"While the FDA considers strangulation caused by feed set tubing used for enteral feeding in children is rare Healthcare professionals should be aware of these events," the agency stated in its notice. Avanos Medical feeding tube This suggests that similar cases might not have been reported to FDA.


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