Notes

Avanos Medical faces a Class I recall of its the feeding tube system linked to 23 deaths in 2015

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

Avanos Medical feeding tube Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an external receiver, and a screen. The system can be utilized in conjunction with the system to stream a live video that shows the procedure of inserting a medical feeding tube into the stomach of the patient. This procedure is carried out to improve accuracy and reducing complications.

Avanos launched a recall earlier in the year to all Cortrak*2 devices which were in use between January 2021 and January 2022. This totaled nearly 630 devices. The devices were first distributed from April 2016 until the beginning of 2016.

The safety incident doesn't count as an recall in the strictest sense. Avanos doesn't ask healthcare professionals to request that the device be returned to the maker. It's merely to ensure that they're using the device in a safe manner.

A feeding tube that is not properly placed could cause damage to vocal cords and lungs. It may also cause severe injury or death. Avanos Medical feeding tube Avanos was notified of more than 60 injuries and 23 deaths in the year 2015 by the FDA. The incidents were all linked to the Cortrak*2 system, which guides the placement of the feeding tube.

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

The FDA issued a March 21 field correction notification in which the Georgia-based firm urged users to confirm the placement of nasogastric tubes as well as the nasoenteric pipe according to institution policies. The company also asked users to attach the safety warning to the system's operating manual and to confirm with Avanos that they've received the updated.

Avanos announced that they would soon issue an updated labeling for the device. It will include the instructions for placing a tube according to their guidelines.

The FDA has issued a second warning on enteral feeding tubes this year. In February, the FDA issued an safety communication warning healthcare providers and parents about the danger of strangulation when children use feeding tubes.

The announcement came in the wake of two deaths in 2021. Each incident was a result of a tubing system that was wrapped around the neck of a baby younger than 2 when the patient wasn't being monitored by staff at the hospital.

https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns Cortrak 2 eternal access system "While the FDA believes that strangulation due to tube feeding into the enteral system in children is rare," the agency noted in its notice. It also suggested that similar cases may not have been reported to the FDA.

Avanos Medical feeding tube
Website: https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges