Notes

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

The FDA has issued the most extreme warning regarding the recall of Avanos Medical's Enteral Feeding Tube Positioning System.

Cortrak 2 eternal access system Cortrak*2 Enteral Access System has an electromagnetic stylet and an external receiver. It also comes with an LCD monitor. When combined, the system offers live video feeds of the process of inserting an medical tube for feeding into a patient's stomach or small bowel with an intention of improving the accuracy of the tube's tip positioning and reducing complications.

Avanos launched a recall earlier in the year to all Cortrak*2 devices that were used between January 2021 to January 2022. https://www.nutritioncare.org/News/General_News/Nasoenteric_Feeding_Tube_Placement_and_Verification/ This totaled nearly 630 devices, which was first distributed from April 2016 until the beginning of 2016.

The safety event is not recall in its true meaning: Avanos does not ask healthcare providers to return the devices back to the manufacturers. Instead, it wants to ensure that they are making use of the devices properly.

If a tube for feeding is not correctly placed, it could cause damage to the vocal cords, lungs or the trachea and cause severe injury or even death. Avanos was notified of the deaths of 23 people and injuries to 60 in 2015 by the FDA. Avanos Medical Cortrak 2 eternal access system The incidents were all linked to the Cortrak*2 system that controls the positioning of the feeding tube.

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

Avanos Medical feeding tube According to FDA, in the March 21 Field Correction Notice the Georgia-based company asked users to "confirm the placement of the nasogastric (and the nasoenteric) tubes in accordance with institutional policy." Avanos has requested that users add a safety warning to their operating manual and confirm they have received the updated.

Avanos announced that they'll soon release updated labeling to the device. It will include the directions to put a tube according to their policies.

This marks the second warning that the FDA has issued in the past year with regards to enteral feeding tubes. In February, the FDA issued the safety warning to parents and healthcare professionals concerning the possibility of strangulation among children who use feeding tubes.

In the wake of two deaths in 2021, the notification was sent. Each time, a tubing system was accidentally wrapped around a child who was less than two years old, even though they were not monitored by caregivers or hospital staff.

"While the FDA believes that serious injury or death from strangulation with tubing for enteral feeding in children is uncommon, healthcare providers and their caregivers must be aware that such events could and do happen," the agency said in the notice and suggested that similar cases might not have been reported to the FDA.


Website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015