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This problem has resulted in the deaths of 23 people and 60 injuries.
The FDA has declared this a Class I Recall, the most serious kind. These devices could cause serious injuries, or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has confirmed Avanos Medical's recall of its Cortrak*2 enteral access system. https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm Beginning on March 21 the 21st of March, 2016, 629 devices were recalls in the U.S.
Cortrak*2 aids clinicians when placing medical feeding tubes in the stomachs or small bowels of patients that need to be fed by the tube.
Cortrak 2 eternal access system The recall was brought on by reports of death and injuries from patients after nasocentric/nasogastric tube mistaken placement. Avanos Medical feeding tube This device is used to aid in the placement of the tubes. If a nasogastric or nasoenteric tube is incorrectly inserted it can cause damage to the vocal cords, lungs, or trachea, resulting in serious injury or death.
According to Avanos’ safety communication the number of deaths was 60 and 23 injuries related to this problem. The adverse events identified included perforation, respiratory failure, and pneumonia, in addition to pleural effusion.
The recall is being leveraged to revise Cortrak*2's guidelines regarding use and intended usage, instructing users to confirm the placement of the tube based on institutional protocols before using the tube to distribute nutrients.
Clinicians were instructed to add the pertinent field correction notice to their operating manual. They should also return the acknowledgement form that came along with the Avanos note. The company is planning to provide users with current labeling as well as confirmation of placement of tubes in accordance to 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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