Notes

Avanos Medical faces Class I recall because of feeding tube connection that led up to 23 deaths.

After seven years of failure in Avanos Medical, Avanos Medical’s Enteral Feeding Tube Placement System has been recalled by the FDA has issued the most severe recall orders.

Avanos Medical feeding tube Cortrak*2 Enteral Access System contains an electromagnetic stylet , as well as an external receiver. The system, when combined with the display monitor, allows live video of the medical feed tube being placed into the stomach of a patient.

Avanos Medical Avanos began a recall earlier in this year of the entire Cortrak*2 device in use between Jan 2021 to Jan 2022. There were 630 units originally distributed from April 2016 and the beginning of.

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The safety event doesn't constitute an recall in the strictest sense: Avanos doesn't ask healthcare professionals for the device to be returned to the company that made it. It's merely to ensure that they're using it correctly.

Cortrak 2 eternal access system A feeding tube that is not properly inserted could result in serious injury or even death. According to FDA, Avanos received reports of 23 deaths, and 60 injuries since 2015, all of them related to the FDA's use of the Cortrak*2 system to guide the placement of the feeding tube.

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

According to the FDA, the Georgia-based company issued a March 21 field correction note that reminded users to confirm the placement of nasogastric and nasoenteric tubs according to institutional policies. https://www.medicaltubingandextrusion.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ Avanos has also asked users to add the safety notice to the operating guideline of the device and verify that they've received the updated.

Avanos announced that it will shortly issue updated labeling for the device, which will include the direction to determine the tube's location in accordance with their facility's policies before using the system to help to install the tube.

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This is the FDA's second warning in relation to tube feeding through the stomach. In February the FDA issued a safety warning to parents and healthcare professionals regarding the danger of strangulation for children who use feeding tubes.

In the wake of two deaths reported in 2021, this notice was issued. The tubing system was not being monitored by staff or caregivers was wrapped around necks and necks of children less than two years old.

"While the FDA believes that strangulation from tubing for the feeding tube in children is unlikely to cause fatal injury or death, caregivers and healthcare providers must be aware of the possibility," the FDA stated in the notice. The FDA also stated that similar cases may not have been reported to the FDA.

https://journals.lww.com/biomedicalsafetystandards/Citation/2022/07150/Avanos_Medical_Cortrak2_Enteral_Access_System.2.aspx
Homepage: https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/