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There were 60 injuries as well as 23 deaths due to this issue.
The FDA has designated this as an Class I Recall, which is the most serious type. Avanos Medical Utilizing these devices can cause serious injury or death.
Sam Brusco Associates Editor05.16.22
The FDA has confirmed Avanos Medical's recall of its Cortrak*2 intramuscular access system. The recall of 629 devices that were distributed between 2016 and 2022 started on the 21st of March.
Cortrak*2 assists clinicians in placing medical feed tubes on patients who require nutrition through the tube.
Due to injuries and deaths due to injuries and deaths, the system was recall. Incorrectly inserting a Nasogastric or Nasoenteric tube could result in severe injury or death.
According to Avanos reports, there were a total of 60 injuries and 23 death related to this issue. There have been several adverse events, including respiratory failure, pneumothorax and perforation as well as pleural effusion and pneumonia.
Cortrak*2 has used the recall process to make revisions to its instructions for its use. The new instructions contain instructions for users to ensure that the tubes are placed in accordance with institutional protocols prior to applying them to provide nutrition.
Clinicians were directed to attach the pertinent field correction notice to their operating manual. https://www.indiegogo.com/individuals/29921650/ Cortrak 2 eternal access system They also need to return the acknowledgement form which came along with the Avanos notice. The company plans to provide users with current labeling, which will include confirmation of tube placement in accordance with the institution's policies prior to the use.
feeding tube placement feeding tube placement
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