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This problem has caused sixty injuries and 23 deaths.
This is a Class I recall issued by FDA that is the most severe type. These devices can cause serious injury or even death.
https://www.ted.com/profiles/40210052 Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical's recall for the Cortrak*2 oral access system. 629 devices made between 2016 and 2022 were recalled, with the first recall happening on March 21.
Avanos Medical Cortrak*2 lets clinicians insert medical feeding tubes into the stomach or small bowel of patients that require nutritional assistance.
https://lexsrv3.nlm.nih.gov/fdse/search/search.pl?match=0&realm=all&terms=https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system In the wake of deaths and injuries, the system was recalled. An error in inserting the Nasogastric or Nasoenteric tube could cause severe injuries or even death.
According to Avanos reports, there were a total of 60 injuries and 23 death in connection with this issue. Pneumothorax (perforation), pneumothorax (perforation), pneumonia, and pleural effusion were all listed as adverse events.
https://www.princeclassified.com/user/profile/1115056 Cortrak*2 will utilize the recall to update its directions for usage and intended use. It will advise users to check the placement of tubes with the help of institutional protocols prior to providing food.
Avanos Mediacal Cortrak 2 Clinicians were also asked to attach the correction notice concerning the issue to the operating book and return the acknowledgement form with the note to Avanos. Avanos plans to offer users the most current labels, along with confirmation of placement of tubes in accordance with the institutional guidelines.
Website: https://lexsrv3.nlm.nih.gov/fdse/search/search.pl?match=0&realm=all&terms=https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system
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