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The Avanos Medical Cortrak*2 Ental Access System was designed to aid trained health professionals with the placement of medically-approved feeding tubes in the small intestines of patients' stomachs. The feeding tube has been linked to 23 deaths since 2015.
There have been substantive reports of injuries and deaths after nasoenteric or nasogastric tubes are misplaced after this device is used to aid in their positioning.
This recall is used to make updates to the device's labeling, which includes the instructions for use as well as intended uses. Users are instructed to verify that the tube is placed in accordance with the guidelines of their establishment prior to applying it to provide nutrition.
https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Incorrectly inserting a Nasogastric or Nasoenteric tube could cause harm to the vocal chords, lungs , or trachea. https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ This could result in serious injury and even the death.
Avanos Medical recalls that there was a total of 60 injuries and 23 deaths from the incorrect placement of nasogastric tubes since 2015. The adverse events that were reported included respiratory failure, pneumothorax, collapsed lung perforation (a opening in the esophagus's wall or lung) and pneumonia (a lung infection), pleural effusion, excess fluid in the lungs and chest cavity, as well as pneumothorax.
Avanos Medical sent a field correction notice on March 21st 2022 to customers who had used the devices between January 2021 & January 2022. The following guidelines were included in the notification.
Check the position of the nasogastric, nasal and other tubes in accordance with institutional policies.
Attach the correction notice from the field describing the issue to the operator's manual.
https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas Cortrak 2 eternal access system Avanos must acknowledge the receipt of the email notification. Avanos Medical
My Website: https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas
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