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This issue has caused more than 23 deaths and 60 injuries.
This is a Class I recall by FDA that is the most serious type. These devices can cause serious injuries, or even death.
Avanos Medical feeding tube Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical as the person responsible for recalling their Cortrak*2 system for enteral access. The recall of 629 devices distributed between 2016 and 2022 started on the 21st of March.
Cortrak*2 permits clinicians to insert medical feeding tubes inside the small bowel or stomach of patients who require nutritional assistance.
Cortrak 2 eternal access system Due to injuries and deaths, the system was recalled. A wrongly placed nasogastric or nasal tube can cause serious injuries or even death.
Avanos Medical According to Avanos the number of incidents has been an estimated 60 injuries and 23 deaths related to this issue. Avanos Medical The adverse events reported included pneumonia, respiratory failure, perforation and pneumonia, in addition to the pleural effusion.
Cortrak*2 has utilized the recall to make updates to its procedures for use. The updated guidelines will contain instructions for users to make sure that tubes are placed in accordance with the guidelines of the institution before making use of them to deliver food.
Clinicians were also advised to attach the amended field notice regarding the issue to Avanos' operating manual, and to return the acknowledgement forms in Avanos' announcement. Cortrak 2 eternal access system Avanos plans to give users an current labeling, which will include confirmation of tube placement in accordance with the institution's policies prior to the use.
Website: https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/
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