Notes

Avanos Medical faces Class I recall for the feeding tube system that has been associated with 23 deaths since 2015.

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

feeding tube placement Cortrak 2 eternal access system Cortrak*2 Enteral Access System has an electromagnetic stylet and an external receiver. It also includes an LCD monitor. The system can be used in conjunction to stream a live video which shows the process of inserting a medical feeding tube in the stomach of the patient. This procedure is carried out in the hope of increasing precision and reducing the risk of complications.

Despite this mission, however, the system has been implicated in dozens of patient injuries, prompting Avanos to issue a recall earlier this year of all Cortrak*2 units used between January 2021 and January 2022, totalling more than 630 devices that were distributed between April 2016 until the beginning of the year.

The safety event isn't a recall , in the literal sense of the word: Avanos is not asking health professionals to return the device back to its manufacturer but rather to ensure they're using them correctly.

If a feeding tube is incorrectly inserted, it can damage the vocal cords, lungs, or trachea which could result in severe injury or even death. Avanos was informed of the deaths of 23 people and injuries to 60 in the year 2015 by the FDA. These incidents were all linked to the Cortrak*2 system that guides the placement of the feeding tube.

Cortrak 2 eternal access system Avanos Mediacal Cortrak 2 There are a variety of injuries that have been reported which include respiratory failure, lung infection and collapsed lung.

The FDA advised users that they need to confirm the that they have placed a nasogastric tube according to their institutional guidelines in the March 21 field correction notification. Avanos has also asked them to add the safety notice to the operating manual for the system and confirm that they've received the latest update.

https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ Avanos said it will soon issue updated labeling for the device. It will include the direction to plot the location of the tube in line with the guidelines of their facility before using the system to assist set up the tube.

This is the FDA’s second caution in relation to enteral-feeding tubes. The FDA issued a safety alert in February alerting parents and healthcare professionals of the possibility of strangulation in children who use feeding tubes.

The announcement came in the wake of two deaths reported 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.

"While FDA believes that death from strangulation resulting from enteral feeding set tubing for children is extremely rare It is crucial that healthcare providers and caregivers are aware that events like this can and do happen," the FDA stated in its notice. The FDA suggested that similar incidents might not have been reported yet.

Cortrak 2 eternal access system
Read More: https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf