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This issue is responsible for at least 60 injuries and 23 fatalities.
This recall was identified by the FDA as a Class I recall. feeding tube placement Avanos Medical It is the most severe type of recall. https://farangmart.co.th/author/avanos-medicalkyym901/ These devices could lead to serious injuries or even death.
Sam Brusco Associate Editor05.16.22
The FDA has identified Avanos Medical’s recall its Cortrak*2 access device for use in the system. 629 devices made between 2016 until 2022 were recalls, with the first recall occurring on the 21st of March.
Cortrak*2 helps clinicians place medical feed tubes in patients that require nutrition via the tube.
The system was recalled because of injuries and deaths resulting from nasocentric or Nasogastric tube misplacement, when it is employed to place these tubes. If a nasogastric tube is incorrectly inserted there could be damage to the vocal cords, lungs, or trachea, resulting in serious injury or death.
According to Avanos, there have been more than 60 injuries and 23 death related to this issue. Numerous adverse events have been reported such as pneumonia, respiratory failure and pneumothorax.
Cortrak*2 will make use of the recall to update its guidelines for use and intended uses. https://www.misterpoll.com/users/avanos mediacal cortrak 2thhr3496 feeding tube placement It will advise users to verify tube placement using institutional protocols before delivering food.
Clinicians were also urged to attach the amended field notice on the problem to Avanos operating manual and to return the acknowledgement forms that came with Avanos announcement. feeding tube placement The users will shortly receive an update to the labels and confirmation that tubes were placed in accordance with the institution's guidelines.
Avanos Medical feeding tube
Homepage: https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
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