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This problem has caused 60 injuries and 23 deaths.
The FDA has declared this a Class I Recall, which is the most serious type. These devices could cause serious injuries and even death.
https://app.glosbe.com/profile/7007565606518000862 Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of its Cortrak*2 user access system. 629 devices distributed between 2016 to 2022 were recalled in the U.S., beginning on March 21.
Cortrak*2 aids clinicians to place medical feed tubes in patients who require nutrition via the tube.
feeding tube placement Avanos Medical feeding tube The device was temporarily recalled due to injury and patient death reports resulting from nasocentric and Nasogastric tube misplacement, when the device is used to help place these tubes. Incorrectly inserting a nasogastric tube or nasoenteric can result in severe injury, and even cause death.
According to Avanos Safety Communication the company has reported 60 injuries and 23 deaths related to this issue. Many adverse events have been reported such as respiratory failure, pneumonia, and pneumothorax.
Cortrak*2 has used the recall process to make revisions to its guidelines for use. The updated instructions will include instruction to users to ensure that the tubes are placed in accordance with institutional protocols prior to using them to deliver nutrition.
Clinicians are also advised to include the field correction note to the operating manual , and return the acknowledgement forms included in the notice to Avanos. The company hopes to soon give users updated labeling. This will include confirmation that the placement of the tube was done according to institutional policies.
https://myclc.clcillinois.edu/web/jeff_test/ttttttutoring/-/message_boards/message/44430157 Avanos Medical feeding tube
My Website: https://lexsrv3.nlm.nih.gov/fdse/search/search.pl?match=0&realm=all&terms=https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/
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