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There have been 60 injuries and 23 deaths as a result of this problem.
The FDA has classified this as a Class I Recall, which is the most severe type. Use of these devices may cause serious injuries or death.
Sam Brusco Associate Editor05.16.22
The FDA has identified Avanos Medical’s recall its Cortrak*2 useal access system. Avanos Medical The recall of 629 devices distributed between 2016-2022 began on March 21.
Avanos Mediacal Cortrak 2 Cortrak*2 helps clinicians place medical feeding tubes in the stomach or small bowels of patients who need to be fed via the tube.
The system's recall was caused by the deaths and injuries of patients resulting from misplacement of nasocentric/nasogastric tubes. These tubes are used to aid in placing them. A mistake in the placement of an Nasogastric tube or Nasoenteric one could result in severe injury or death.
According to Avanosthe safety announcement the number of deaths was 60 and 23 injuries that were related to the issue. https://www.openstreetmap.org/edit There were several adverse events, including pneumothorax, respiratory failure and perforation as well as pleural effusion and pneumonia.
Cortrak*2 will make use of the recall process to modify its guidelines for use and intended use. It will instruct users to check the placement of tubes using institutional protocols before delivering nutritional supplements.
Clinicians were also encouraged to attach the amended field notice regarding the issue to Avanos' operating manual, and return the acknowledgement forms that came with Avanos' notice. https://dohabb.com/index.php?page=user&action=pub_profile&id=1634232 Avanos plans to offer users current labeling, which will include confirmation of the placement of tubes in accordance with the institution's policies prior to usage.
https://list.ly/rytterjoseph126
Homepage: https://dohabb.com/index.php?page=user&action=pub_profile&id=1634232
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