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This issue has caused more than 23 deaths and 60 injuries.
The recall has been classed by FDA as a class I recall. This is the most serious form of recall. Utilizing these devices can cause serious injury or death.
Cortrak 2 eternal access system Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical as the person responsible for recalling their Cortrak*2 system of enteral access. Since March 21st in 2016, 629 of the devices were recalls in the U.S.
Cortrak*2 lets clinicians insert medical feeding tubes in the small bowel or stomach of patients who require nutrition.
The recall was caused by injury and death reports from patients who suffered from nasocentric or nasogastric mistaken placement. The device is used for helping to place the tubes. Cortrak 2 eternal access system If a nasogastric, or nasoenteric tube is incorrectly inserted, damage can occur to the vocal cords, lungs, or trachea, resulting in grave injury or even death.
According to Avanos safety information the issue has resulted in 60 injuries and 23 deaths. There were a variety of adverse events, such as respiratory failure, pneumothorax and perforation, pneumonia and pleural effusion.
Cortrak*2 will use the recall to revise its guidelines for use and intended usage. It will instruct users to check the placement of tubes with the help of institutional protocols prior to providing food.
Clinicians were instructed to attach the relevant field correction notice to their operating manual. Avanos Medical https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system They should also return the acknowledgement slip included along with the Avanos notification. Avanos Medical The company plans to offer users current labeling, which will include confirmation of tube placement according to institutional policies before the use.
Website: https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/
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