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The Avanos MedicalCortrak*2 Enteral Access System was designed to aid healthcare professionals with training to insert medical feeding tubes in the stomach or small bowel of patients who need to be fed via the tube. Avanos Medical feeding tube There were 23 deaths attributed to the feeding tube since 2015.
Patients have died and injuries because of the inadvertently placed nasogastric/naso devices.
This recall is being used for updates to the device’s labeling and instructions for use. Avanos Medical https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ The update instructs users to verify that the tube was set up according to the institution's guidelines prior to making use of the tube for food delivery.
https://www.nutritioncare.org/News/General_News/Nasoenteric_Feeding_Tube_Placement_and_Verification/ If you do not insert correctly a Nasogastric tube or Nasoenteric tube can cause harm to the vocal chords, lungs , or the trachea. This could result in serious injury and even the death.
Avanos Medical has issued a recall communication stating that since 2015, there has been 60 patient deaths and 23 injuries resulting from misplacement nasogastric feeding tube. Pneumothorax (collapsed lung) or pneumothorax ("collapsed lung"), perforation ("hole in the wall, or bowel of the lung), pneumonia (a bacteria-related infection that affects the lung) and the pleural liquid (excess fluid between the lungs).
Avanos Medical issued on March 21, 2022, a field correction notice to customers using these devices between January 20,21 and January 20,22. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Avanos Medical The notice provided the following information:
Use nasogastric or Nasoenteric tubs in accordance with the institution's policies.
Attach the corrective notice within the field of the operator's handbook.
Avanos Medical Avanos Health Medical requests to return the acknowledgement form with the email notification Avanos Medical
Website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
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