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This issue has led to sixty injuries and 23 deaths.
The recall has been classed by FDA as a class I recall. Avanos Medical feeding tube This is the most serious kind. The devices could cause severe injuries or even death.
Sam Brusco is Associate Editor05.16.22
The FDA has identified Avanos Medical as the company responsible for recalling its Cortrak*2 system of access to the enteral. 629 devices, distributed from 2016 and 2022, were recalled by U.S. starting on March 21.
Cortrak*2 is a device that allows doctors to insert medical feeding tubes in patients' stomachs or small bowels.
Avanos Medical feeding tube The system's recall was caused by patient deaths and injury following an error in placement of the nasocentric or nasogas. These tubes are used to aid in insertion. An incorrectly placed nasogastric/nasoenteric tube can cause serious injury or death.
Avanos Medical feeding tube Cortrak 2 eternal access system According to Avanos' safety communications there were 60 injuries and 23 deaths related to this issue. Many adverse events have been reported such as pneumonia, respiratory failure and pneumothorax.
Cortrak*2 is using this recall to improve the guidelines for usage and intended use. The users will have to confirm the placement of tubes in accordance with institutional protocols, before they can deliver nutrition.
Clinicians were also urged to attach the amended note in the field on the issue to Avanos operating manual and return the acknowledgement forms that came with Avanos announcement. Avanos Medical Avanos Medical feeding tube Avanos plans to give users an current labeling, which will include confirmation of tube placement as per the policies of the institution prior to use.
Homepage: https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/
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