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This has led to more than 23 deaths and 60 injuries.
The FDA has classified this as an Class I Recall, the most severe type. These devices can cause serious injuries or even death.
https://www.metooo.io/u/62dd1a4a462a6d715d30a298 Avanos Mediacal Cortrak 2 Sam Brusco, Associate Editor05.16.22
The FDA has confirmed Avanos Medical's recall of their Cortrak*2 enteral access system. 629 devices manufactured between 2016 until 2022 were recalls in the U.S., beginning on the 21st of March.
Avanos Mediacal Cortrak 2 Cortrak*2 aids clinicians when placing medical feeding tubes into the stomach or small bowels of patients who need to be fed through the tube.
The recall was triggered by death and injury reports from patients who suffered from nasocentric or nasogastric mistaken placement. This device is utilized to assist in placing these tubes. Incorrectly inserting a Nasogastric or Nasoenteric tube could cause severe injury or death.
According to Avanos’ safety communication there were 60 deaths and 23 injuries related to the issue. Avanos Mediacal Cortrak 2 A variety of adverse events were identified which included respiratory failure, pneumonia, and pneumothorax.
Cortrak*2 has utilized the recall process to make revisions to its guidelines for use. http://pandora.nla.gov.au/external.html?link=https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html The new instructions include instruction to users to ensure that the tubes are placed in accordance with the guidelines of the institution before applying them to provide nutrition.
Clinicians were also advised to attach the corrected field notice regarding the issue to Avanos' operating manual, and to return the acknowledgment forms in Avanos' notice. The company is planning to offer users the most current labeling, along with confirmation of placement of tubes in accordance to institutional policies.
feeding tube placement
Website: http://pandora.nla.gov.au/external.html?link=https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html
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