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Avanos Medical faces Class I recall due to feeding tube system connection up to 23 deaths.

After seven years of failures for Avanos Medical's Enteral Feeding Tube Placement System The FDA has designated the most serious category for recalls.

Cortrak*2 Enteral Access System contains an electromagnetic stylet as well as an external receiver. It can be combined to provide a live feed that illustrates the process of inserting a medical feed tube into the stomach of a patient. This procedure is carried out to improve accuracy and reducing complications.

Avanos issued the recall earlier in the month of every Cortrak*2 device that was that were used between January 20,21 and January 20,22. The recall involved more than 630 devices.

https://arcieve.blogspot.com/2022/05/avanos-medical-recalls-cortrak2-enteral.html The safety event doesn't constitute an recall in the strictest sense: Avanos isn't asking healthcare providers to request that the device be returned to the maker. It's simply to make sure that they're using it correctly.

A tube for feeding that has not been properly inserted could cause grave injury and even cause death. https://www.cyberera.com.ng/2022/05/17/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/ feeding tube placement Avanos was notified of more than 60 injuries and 23 deaths in 2015 by the FDA. Avanos Medical feeding tube The incidents were all connected to the Cortrak*2 system, which guides the installation of the feeding tube.

The reported injuries include respiratory failure and lung collapse, lung infection the pleural effusion and holes in the lungs' walls as well as the esophagus and bowel.

Avanos Medical feeding tube According to FDA the Georgia-based firm advised users in its March 21 field correct notification to "confirm the use of tubs in nasogastric/nasoente to institution policies". feeding tube placement Avanos advised users to attach the safety notification to the system's operation manual and verify with Avanos that the update was accepted.

Avanos has announced it will soon issue updated labeling for the device that will include a direction to plot the tube's location in accordance with their facility's policies before using the system to assist to install the tube.

The FDA has issued a second warning regarding enteral-feeding tubes. The FDA released a safety communications in February warning parents, healthcare providers, and children about the possibility of strangulation from tubes for feeding.

The announcement came in the wake of two reports of deaths in 2021. In both cases, a tubing device was discovered to be wrapped around the neck of patient under 2 years old, while they were not being watched by caregivers or hospital workers.

Avanos Mediacal Cortrak 2 "While FDA believes that death from strangulation resulting from tubing for feeding tubes used in the enteral system for children is uncommon, it's important that healthcare providers and caregivers are aware that such events could and do occur," the FDA stated in the announcement. The agency also suggested that similar incidents might not have been reported.


Read More: https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/