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The Avanos Medical Cortrak 2 Entry Access Systems is created to assist trained healthcare professionals to insert medical feeding tubes into the stomach or small bowel of patients who require nutrition. Avanos Medical In 2015, however, 23 patients have died due to complications relating to the feeding tube.
There have been substantive reports of injuries and deaths after nasoenteric or nasogastric tubes have been misplaced when the device is used to help with their positioning.
This recall is being utilized to make changes to the labeling of the device and instructions for use. Avanos Medical feeding tube Users are instructed to verify that the tube is placed in accordance with the specifications of their establishment prior to applying it to provide nutrition.
Avanos Mediacal Cortrak 2 Avanos Medical feeding tube If you do not insert correctly a Nasogastric tube or Nasoenteric tube could cause damage to the vocal chords, lungs , or trachea. Cortrak 2 eternal access system This can lead to grave injury and possibly death.
Avanos Medical's recall notification declared that there were sixty-three injuries and 23 deaths linked to the misplacement or removal of nasogastric feed tubes during using the CORTRAK*2 enteral Access System. This occurred since the year 2015. The adverse events that were identified were respiratory failure, pneumothorax or collapsed lung, perforation (a opening in the esophagus's wall or lung) and pneumonia (a lung infection) and pleural effusion. excessive fluid between the lungs and the chest cavity, and pneumothorax.
On the 21st of March 2022 Avanos Medical issued a field correction notice to its customers who utilized these devices between January 2021 and January 2022. The following instructions were contained in the notice.
Cortrak 2 eternal access system Verify the placement of nasogastric/nasoenteric according to the institutional guidelines
Attach the correct notice in the field regarding the issue to the operator's guide.
Avanos Health Medical asks that you return the acknowledgment form with the email notice
Website: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its
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