Notes

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

Seven years after adversity for the Enteral Feeding Tube Placement System Avanos Medical's enteral feeding tube placement system, the FDA has given its most serious designation for an immediate recall of the device.

Cortrak*2 Enteral Access System has an electromagnetic stylet and an external receiver. It also includes a display monitor. When combined it provides a live feed of the process of inserting the medical feeding tube in the stomach of a patient, or in the small bowel, with an intention of improving the accuracy of the tube's tip placement and reducing the risk of complications.

Avanos was not pleased with the results and announced an immediate recall of all Cortrak*2 units between January 2021 and January 2022. The recall affected approximately 630 units which were distributed between April 2016 & the start of this year.

Avanos Medical feeding tube The safety event doesn't constitute a recall in any strict sense: Avanos does not ask healthcare providers to have the device returned to the manufacturer. It's simply to make sure that they're using the device in a safe manner.

A feeding tube that is not properly placed can damage vocal cords and lungs. https://arcieve.blogspot.com/2022/05/avanos-medical-recalls-cortrak2-enteral.html https://zephyrnet.com/sv/fda-identifies-avanos-medicals-cortrak-2-eas-recall-as-class-i/ It can also result in serious injury or even death. Avanos has reported more than 23 deaths and 60 injuries since 2015, FDA stated. All of them were directly related to the FDA's Cortrak*2 system used to place a feeding tube.

The most common injuries include respiratory failure and collapsed lung, lung infections, pleural effusion , and cracks in the wall of the stomach, bowel, and lungs.

According to FDA the Georgia-based firm reminded users in its March 21 field correct note to "confirm the use of tubs in nasogastric/nasoente to the institution's policies". feeding tube placement Avanos has also asked them to attach the safety note to the operating guideline of the device and verify that they have received the update.

feeding tube placement Avanos has announced that they will soon issue updated labeling for its product. This will include instructions for locating the position of the tube according to their facility's policies.

This is the second FDA warning about enteral feeding tubes this year. feeding tube placement In February, the FDA issued a safety alert to parents and healthcare providers about the risk of strangulation for children who are using feeding tubes.

The warning came following two deaths were reported in 2021. Cortrak 2 eternal access system In each instance the tubing system was discovered to have inadvertently wrapped around the neck of a patient younger than 2 when they weren't directly observed by their staff members or caregivers.

"While FDA believes strangulation of children with enteral feeding tubes in children is rare, caregivers and healthcare providers must be aware that such events can and will occur," the FDA said in its notice. Cortrak 2 eternal access system They also suggested that the FDA may have not yet received reports on similar cases.

https://www.productsafety.gov.au/recalls/avanos-medical-australia-pty-ltd-%E2%80%94-mic-gastrostomy-feeding-tubes-expanded-recall
Website: https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/