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This problem has caused 60 injuries and 23 deaths.
This is a Class I recall issued by FDA which is the most severe type. These devices can lead to serious injuries and even death.
Sam Brusco is Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of the Cortrak*2 user access system. Cortrak 2 eternal access system The recall of 629 devices distributed between 2016 and 2022 started on March 21.
Cortrak*2 is an instrument that lets doctors place medical feeding tubes inside patients stomachs, or small bowels.
Avanos Medical feeding tube The device was temporarily recalled because of injury and deaths resulting from nasocentric or nasogastric tube misplacement when it is employed to place these tubes. If a nasogastric or nasoenteric tube is incorrectly inserted, damage can occur to the vocal cords, lungs, or trachea, which can result in grave injury or even death.
https://content.govdelivery.com/accounts/USFDA/bulletins/317bc54 According to Avanos reports, there were an estimated sixty injuries and 23 deaths connected to this problem. https://www.ecri.org/search-results/member-preview/hrcalerts/pages/hrcalerts011718_fda Pneumothorax (perforation), pneumothorax (perforation), pneumonia, and pleural effusion were all identified as adverse events.
Avanos Medical Cortrak 2 eternal access system The recall is used to revise Cortrak*2's guidelines on use and intended use, instructing users to confirm the placement of the tube based on protocol guidelines before using the tube to distribute nutrients.
Avanos Medical Clinicians were advised to add the corrective field notice regarding the issue to their operating manual and to return the acknowledgment form that was provided in the notice to Avanos. The company hopes to soon offer users updated labels. https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf This will include confirmation that the placement of the tube was carried out in accordance with institutional policies.
Read More: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement/
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