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There are 60 reported injuries and 23 deaths due to this issue.
The FDA has classified this as a Class I recall, which is the most serious kind of recall. These devices can cause grave injuries, or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has confirmed Avanos Medical's recall of its Cortrak*2 oral access device. 629 devices, which were distributed between 2016 - 2022, were recalled by the U.S. starting on March 21.
https://buystocklot.com/user/profile/202916 Cortrak*2 helps clinicians place medical feeding tubes into the stomach or small bowels of patients who need to be fed via the tube.
Avanos Medical The system's recall was due to the deaths and injuries of patients resulting from the incorrect placement of nasocentric/nasogastric tubes. Avanos Medical These tubes aid in placing them. If a nasogastric tube is not correctly inserted, damage can occur to the vocal cords, lungs, or trachea, resulting in severe injury or death.
feeding tube placement http://pandora.nla.gov.au/external.html?link=https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/ According to Avanos safety announcement the problem has led to 60 injuries and 23 deaths. Pneumothorax, pneumothorax (perforation) pneumonia, and pleural effusion were all identified as adverse events.
Cortrak*2 is using the recall to make updates to its procedures for use. The new instructions contain instructions for users to make sure that tubes are placed according to the guidelines of the institution before using them to deliver nutrition.
Clinicians were directed to attach the pertinent field correction notice in the operating manual. They also need to return the acknowledgement form which came with the Avanos notification. Avanos is hoping to provide users updated labels. This will include confirmation that the placement of the tube was done according to institutional policy.
Read More: http://pandora.nla.gov.au/external.html?link=https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/
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