Notes

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

After seven years in which Avanos Medical's enteral tube placement system was plagued by unlucky luck and mishaps, the FDA issued its most serious order to issue a recall.

Cortrak*2 Enteral Access System has an electromagnetic stylet and an external receiver. Avanos Medical It also comes with a display monitor. In combination with the display monitor, the system provides a live stream of the medical feed tube being placed in the patient's stomach.

Avanos issued a recall earlier this month of all Cortrak*2 devices in use between January 20,21 between January 20,22 and January 20,21. https://peatix.com/user/16332838 The recall affected nearly 630 devices.

The safety incident doesn't count as a recall in any strict sense: Avanos doesn't ask healthcare professionals to have the device returned to the manufacturer. It's simply to make sure that they're using it correctly.

https://www.metooo.io/u/640aacb1ee513771ed4f47be A feeding tube installed incorrectly can cause damage to vocal cords or the tracheas. Avanos has reported 60 injuries and 23 deaths since 2015, FDA stated. All of them were connected to the FDA's Cortrak*2 device used to insert a feeding tube.

Avanos Medical These injuries could include respiratory failure, collapsed lungs lung infection, as well as holes in the lung's walls and esophagus.

The FDA advised users that they need to confirm the the placement of a nasogastric or nasoente tube in accordance with their institution policies in the March 21 field correction notification. Avanos is advising users to add a safety warning to their operating manual and to confirm they have received the updated.

https://musescore.com/user/61880737 Avanos announced that it will shortly provide updated labels for the device that will include the direction to determine the tube's location in accordance with the guidelines of their facility before using the system to assist install the tube.

This is the FDA's second warning of the year for enteral feeding tubes. https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system In February, FDA issued a safety warning to healthcare providers and parents regarding the dangers of strangulation in children using feeding tubes.

Avanos Medical This announcement was made due to two deaths reported in 2021. Every time, a tube system was accidentally wrapped around a child under two years of age while they were not closely monitored by hospital staff or caregivers.

"While FDA believes strangulation of children who have enteral feeding set tubes is uncommon in children caregivers and healthcare professionals should be aware that these events could and do occur," the FDA said in the announcement. They also suggested that the FDA has not yet received any reports about similar cases.


Website: https://myclc.clcillinois.edu/web/jeff_test/ttttttutoring/-/message_boards/message/47960056