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This issue is responsible for at least 60 injuries , and 23 fatalities.
This recall is classified by FDA as a class I recall. Avanos Medical This is the most serious kind. These devices could lead to grave injuries, or even death.
https://avanos.com/investor-news/response-to-inquiries-about-the-avanos-cortrak-2-voluntary-field-correction/ Sam Brusco is Associate Editor05.16.22
The FDA has identified Avanos Medical’s recall its Cortrak*2 user access system. feeding tube placement Since March 21st the 21st of March, 2016, 629 devices were recalled in the U.S.
Cortrak*2 allows clinicians to place medical feeding tubes in the stomach or small bowel of patients who require nutrition.
The system's recall was due to the deaths and injuries of patients resulting from the incorrect placement of nasocentric/nasogastric tubes. Avanos Medical These tubes aid in the placement of them. A nasogastric, or the nasoenteric tube, that is not correctly inserted could cause injury to the vocal chords and the trachea. This could lead to serious injuries, or death.
feeding tube placement According to Avanos the number of incidents has been more than 60 injuries and 23 death related to this issue. Adverse events reported included respiratory failure, pneumothorax, perforation, pneumonia, as well as the development of pleural effusion.
Cortrak*2 will utilize the recall to revise its guidelines for use and intended use. It will also instruct users to verify tube placement with the help of institutional protocols prior to providing food.
Clinicians were advised to attach the corrective field note about the issue in their operating manual and return the acknowledgement form which was included with the notice to Avanos. Avanos will shortly be able to provide updated labels to patients, as well as confirmation of the placement of tubes in accordance with the institutional guidelines.
feeding tube placement
Read More: https://avanos.com/investor-news/response-to-inquiries-about-the-avanos-cortrak-2-voluntary-field-correction/
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