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This issue has been responsible for the deaths of 60 people and 23 injuries.
The recall is classed by FDA as a class I recall. This is the most serious form of recall. Avanos Mediacal Cortrak 2 Avanos Medical feeding tube These devices can cause serious injuries or even death.
Avanos Mediacal Cortrak 2 Sam Brusco Associate Editor05.16.22
The FDA has confirmed the recall by Avanos Medical of its Cortrak*2 enteral access system. Avanos Mediacal Cortrak 2 Beginning on March 21 the 21st of March, 2016, 629 devices were recalls in the U.S.
Cortrak 2 eternal access system Cortrak*2 aids clinicians to place medical feeding tubes into the stomach or in the small bowels of patients needing to receive nutrition via tube.
The recall was brought on by injury and death reports of patients suffering from nasocentric/nasogastric tube misplacement. This device is utilized to aid in the placement of the tubes. If a nasogastric, or nasoenteric tube is inserted incorrectly, damage can occur to the vocal cords, lungs, or trachea, which can result in grave injury or even death.
https://www.fcc.gov/fcc-bin/bye?https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding According to Avanos' safety communications, there were 60 injuries and 23 deaths attributed to this issue. There were several adverse events that occurred, including respiratory failure, pneumothorax and perforation as well as pleural effusion and pneumonia.
Cortrak 2 eternal access system Cortrak*2 is using the recall to make changes to its guidelines to use. The updated instructions will provide users with a way to verify that tubes are placed according to institution protocols before using them to deliver nutrition.
Avanos Medical feeding tube Clinicians were urged to attach the corrective notice for field use regarding the issue to their operating manual and to return the acknowledgment form that was enclosed with the notice to Avanos. The users will shortly receive an update to the labels and confirmation that the tubes were placed in accordance with the institution's guidelines.
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