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This is the reason for 60 deaths and 23 injuries.
The recall was classified by the FDA as a Class I recall. It is the most severe type of recall. The devices could result in severe injuries or even death.
Sam Brusco Associate Editor05.16.22
The FDA has confirmed Avanos Medical's recall of Cortrak*2 entry access system. The recall of 629 devices that were distributed between 2016 and 2022 started on March 21.
Cortrak*2 permits clinicians to insert medical feeding tubes into the small bowel or stomach of patients who require nutritional assistance.
Cortrak 2 eternal access system The recall of the system was due to patient deaths and injury following an error in placement of the nasocentric or nasogas. https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm These tubes aid in the placement of them. If a nasogastric or nasoenteric tube is inserted incorrectly, damage can occur to the vocal cords, lungs or the trachea, leading to severe injury or death.
Avanos Medical feeding tube According to Avanos Safety communications, there were 60 injuries and 23 deaths attributed to this incident. Pneumothorax and pneumothorax (perforation), pneumonia, and pleural effusion have all been reported as adverse events.
Avanos Mediacal Cortrak 2 Cortrak*2 has used this recall to improve the instructions for its usage and intended use. Avanos Medical feeding tube The users will have to verify the location of the tubes according to established protocols before they can be used to provide nutrition.
Clinicians were instructed to add the pertinent field correction notice in the operating manual. Avanos Medical feeding tube Avanos Medical feeding tube They must also return the acknowledgement form included along with the Avanos notice. Avanos will shortly be able provide the latest labels to patients, as well as confirmation of tube placement according to the policies of the institution.
Read More: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system
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