Notes

Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This problem has resulted in the deaths of 23 people and 60 injuries.

This recall has been classified by FDA as a class I recall. This is the most serious form of recall. These devices can cause serious injuries, and even death.

Sam Brusco is Associate Editor05.16.22

The FDA has identified Avanos Medical's recall of their Cortrak*2 entry access system. Avanos Medical Beginning on March 21, 2016, 629 devices were recalled in the U.S.

feeding tube placement Cortrak*2 aids clinicians to place medical feeding tubes inside the stomach or small bowels of patients who require nutrition through the tube.

https://anotepad.com/notes/rgen9cca The recall of the system was caused by patient deaths and injury following misplacement of nasocentric/nasogastric tubes. These tubes assist in insertion. Avanos Medical feeding tube An incorrectly placed nasogastric/nasoenteric tube could cause severe injury or death.

https://canvas.instructure.com/eportfolios/1549424/Home/Avanos_Medical_Recalls_Cortrak2_Enteral_Access_System_for_Risk_of_Misplaced_Enteral_Tubes_Could_Cause_Patient_Harm According to Avanos' safety communication There have been 53 deaths and 60 injuries in connection with this incident. feeding tube placement A variety of adverse events have been reported, including respiratory failure, pneumonia, and pneumothorax.

Cortrak*2 has used this recall to improve its instructions for use and intended uses. Users must confirm the proper placement of the tubes according to established protocols before they can deliver nutrition.

Clinicians were also encouraged to attach the corrected field notice regarding the problem to Avanos' operating manual, and to return the acknowledgement forms included in Avanos' announcement. Avanos will shortly be able to provide updated labeling for users, which will include confirmation of tube placement in accordance with the institutional guidelines.


Homepage: https://pastelink.net/gx8c1jxz