Notes

Avanos Medical faces Class I recalls for its feeding tube systems connected to 23 deaths in 2015

After seven years of failures with Avanos Medical's Enteral Feeding Tube Placement Systems, the FDA has designated the most serious class for recalls.

Avanos Mediacal Cortrak 2 Cortrak*2 Enteral Access System has an electromagnetic stylet and an external receiver. It also includes an LCD monitor. When used together with the display monitor, the system provides a live stream of the medical feed tube that is placed inside the patient's stomach.

Avanos announced a recall earlier in the year, affecting all Cortrak*2 units that were used between January 2021 and January 2022. Cortrak 2 eternal access system It was nearly 630 devices. They were first distributed between April 2016 to the beginning of the year.

The safety incident isn't recall in its true meaning: Avanos does not ask healthcare providers to return the devices back to the manufacturers. Cortrak 2 eternal access system Instead, it would like to make sure users are making use of the devices in a safe manner.

If a feeding tube is not properly inserted, it can cause damage to the vocal cords, lungs or trachea and cause severe injury or even death. In fact, Avanos has received reports of 23 deaths and 60 injuries since the year 2015 The FDA declared, all of which were related to the the Cortrak*2 system to guide the placement of the feeding tube.

There are several injuries that have been documented such as respiratory failure, lung infection and collapsed lung.

According to FDA, the Georgia-based company advised users in its March 21 field notification to "confirm placement nasogastric/nasoenteric tubs according to institution policies". feeding tube placement Avanos has requested that users include a safety note in their operating manuals and verify they've received the new.

Avanos said it will soon issue updated labeling for the device. Avanos Medical feeding tube It will contain the directions to map out a tube's placement in accordance the policies of their facility prior to using the system to assist set up the tube.

Avanos Mediacal Cortrak 2 This marks the second warning that the FDA has issued this year in relation to the use of enteral feeding tubes. The FDA issued an safety announcement in February warning healthcare professionals and parents about the dangers of strangulation in the event that children are using tubes for feeding.

The announcement came in the wake of two deaths were reported in 2021. Each time, a tubing system was inadvertently wrapped around a baby under two years old while they were not closely monitored by the hospital staff or caregivers.

"While the FDA believes that strangulation using enteral feed set tubing in children is uncommon, healthcare providers should be aware of these events," the agency stated in the notice. This suggests that similar cases might not have been reported to the FDA.


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