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This issue has been responsible for 60 deaths and 23 injuries.
The FDA has declared this a Class I Recall, the most serious type. These devices could lead to grave injuries, or even death.
Sam Brusco is Associate Editor05.16.22
The FDA has identified Avanos Medical as the person responsible for recalling their Cortrak*2 system of access to the enteral. 629 devices, distributed between 2016 - 2022, were recalls by the U.S. starting on March 21.
Cortrak*2 lets clinicians insert medical feeding tubes in the stomach or small bowel of patients that require nutritional assistance.
The system's recall was due to the deaths and injuries of patients resulting from an error in placement of the nasocentric or nasogas. These tubes assist in the placement of them. Avanos Medical A mistake in the placement of a Nasogastric or Nasoenteric tube could cause severe injuries or even death.
https://sharp-skov-2.technetbloggers.de/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cause-patient-harm-1653281260 According to Avanos’ safety communication there were 60 deaths and 23 injuries resulting from the issue. https://notes.io/qwA6p The adverse events that were reported include respiratory failure, pneumothorax, perforation, pneumonia, as well as the pleural effusion.
https://www.click4r.com/posts/g/4380895/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cause-patient-harm Cortrak*2 will make use of the recall to revise its instructions for usage and intended usage. feeding tube placement It will instruct users to ensure the tube is placed with the help of institutional protocols prior to providing food.
Clinicians were also advised to attach the corrected field notice regarding the problem to Avanos' operating manual, and to return the acknowledgment forms that came with Avanos' announcement. The company plans to offer users new labeling and confirmation of tube placement in accordance with the institution's policies prior to the use.
Homepage: https://sharp-skov-2.technetbloggers.de/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cause-patient-harm-1653281260
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