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This issue has caused 60 injuries and 23 deaths.
This recall has been identified by the FDA as an Class I recall. https://prais.paho.org/es/avanos-medical-recalls-cortrak2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cause-patient-harm/ Avanos Medical feeding tube It is the most severe type of recall. Use of these devices may cause serious injuries or death.
Avanos Medical Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of the Cortrak*2 user access system. 629 of the devices produced between 2016 until 2022 were recalls, with the first recall occurring on the 21st of March.
Cortrak*2 allows clinicians to place medical feeding tubes inside the stomach or small bowel of patients who require nutrition.
The device was temporarily recalled due to injury and patient death reports following nasocentric or Nasogastric tube misplacement while it is employed to help to insert these tubes. Cortrak 2 eternal access system Avanos Mediacal Cortrak 2 Avanos Medical feeding tube If a nasogastric or nasoenteric tube is inserted incorrectly it can cause damage to the vocal cords, lungs or trachea, which can result in serious injury or death.
According to Avanos reports, there were an estimated 60 injuries and 23 deaths in connection with this issue. Adverse events reported included respiratory failure, pneumothorax, perforation, pneumonia, and the development of pleural effusion.
feeding tube placement Cortrak*2 will use this recall to update the instructions for its usage and intended use. feeding tube placement The users will have to verify the location of tubes based on institutional protocols, before they are able to deliver nutritional supplements.
Clinicians were also encouraged to attach the corrected field notice on the issue to Avanos operating manual and to return the acknowledgment forms that came with Avanos' notice. The company is expected to be able provide the latest labels to patients, as well as confirmation of tube placement according to the policies of the institution.
Website: https://www.medicaltubingandextrusion.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/
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