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The issue has caused at least 60 injuries and 23 fatalities.
This is a Class I recall issued by FDA that is the most serious type. Avanos Medical feeding tube These devices can cause serious injury or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of its Cortrak*2 oral access device. The recall of 629 devices distributed from 2016 to 2022 began on March 21.
Cortrak*2 assists clinicians in placing medical feeding tubes in the stomach or in the small bowel of patients needing to receive nutrition through the tube.
https://journals.lww.com/biomedicalsafetystandards/Citation/2022/08150/Avanos_Cortrak_2_Enteral_Access_System.17.aspx The recall was initiated because of reports of injuries and even death among patients after the incorrect placement of gastric or nasocentric tubes. Avanos Medical feeding tube The device is used to place the tubes. A nasogastric, or the nasoenteric tube, which is not properly placed could result in damage to the vocal cords or trachea. This could lead to severe injury or death.
https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system According to Avanos safety announcement the issue has resulted in sixty injuries and 23 deaths. Cortrak 2 eternal access system Pneumothorax (perforation), pneumothorax (perforation), pneumonia, and pleural effusion were all identified as adverse events.
This recall will be utilized to modify Cortrak*2's guidelines on use, intended use, and remind users to verify tube placement in accordance with institutional guidelines prior to using the tube to provide nutrients.
Clinicians were also asked to attach the correction notice about the problem to the operating book and then return acknowledgment forms along with the notification to Avanos. The company plans to offer users updated labeling, including confirmation of tube placement as per the policies of the institution prior to use.
https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause#:~:text=Reason%20for%20Recall,to%20help%20with%20their% 20placement. Cortrak 2 enteral access system
My Website: https://recalls-rappels.canada.ca/en/alert-recall/cortrak-2-enteral-access-system
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