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There were 60 injuries as well as 23 deaths related to this problem.
The FDA has classified this as an Class I Recall, which is the most serious type. Use of these devices may result in serious injuries or even death.
Avanos Medical Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical's recall of its Cortrak*2 useal access system. Since March 21st, 2016, 629 devices were recalled in the U.S.
Cortrak*2 aids clinicians to place medical feed tubes on patients who require nutrition through the tube.
This recall was initiated because of reports of injuries and death in patients following misplacement of nasocentric or gastric tubes. Avanos Medical The device is used to place the tubes. Avanos Medical A mistake in the placement of a Nasogastric or Nasoenteric tube could result in severe injury or death.
As per Avanos safety information, this issue has caused 60 injuries and 23 deaths. The adverse events that were mentioned included respiratory failure, perforation, and pneumonia, in addition to pleural effusion.
Cortrak*2 will utilize the recall to update its directions for usage and intended usage. It will also instruct users to check the placement of tubes with the help of institutional protocols prior to providing food.
Clinicians were instructed to attach the pertinent field correction notice in the operating manual. Avanos Medical https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement They should also return the acknowledgement slip that came along with the Avanos notification. Users will soon receive updated labels and confirmation that the tubes were placed in accordance with the institution's guidelines.
Read More: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
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