Expires in 11 months
05 July 2022
This problem has caused 60 injuries, and 23 deaths.
feeding tube placement This recall is classified by FDA as a class I recall. This is the most serious form of recall. Avanos Medical feeding tube These devices could cause serious injuries or even death.
Cortrak 2 eternal access system https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/ Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of the Cortrak*2 oral access system. Starting on March 21, 2016, 629 devices were recalled in the U.S.
feeding tube placement Cortrak*2 permits clinicians to insert medical feeding tubes inside the small bowel or stomach of patients who require nutritional assistance.
The device was temporarily recalled because of injury and deaths resulting from nasocentric or nasogastric tube misplacement when the device is used to help place these tubes. If a nasogastric or nasoenteric tube is incorrectly inserted it can cause damage to the vocal cords, lungs, or trachea, which can result in serious injury or death.
As per Avanos safety communication the problem has led to 60 injuries and 23 deaths. Adverse events reported included pneumothorax, respiratory failure, perforation, pneumonia and the development of pleural effusion.
Cortrak*2 is using the recall to make updates to its instructions to use. feeding tube placement The updated instructions will include instruction to users to ensure that the tubes are placed according to institutional protocols prior to making use of them to deliver food.
Clinicians were required to attach the correct notice concerning the issue in the operating book and return acknowledgment forms along with the notice to Avanos. Avanos Medical https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html The company plans to provide users with current labeling, as well as confirmation of placement of tubes according to the policies of the institution.