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This is the reason for the deaths of 60 and 23 injuries.
This recall has been identified by the FDA as classified as a Class I recall. feeding tube placement It is the most serious type of recall. The use of these devices could cause serious injuries or death.
Sam Brusco, Associate Editor05.16.22
The FDA has confirmed Avanos Medical’s recall of its Cortrak*2 intramuscular accessibility system. http://pandora.nla.gov.au/external.html?link=https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview Beginning on March 21 in 2016, 629 of the devices were recalled in the U.S.
Cortrak*2 assists clinicians in placing medical feed tubes in patients who require nutrition through the tube.
The device was removed due to injury and patient death reports following nasocentric or Nasogastric tube misplacement, when it is employed to place these tubes. Avanos Mediacal Cortrak 2 http://smartbabel.co.uk/user/profile/688242 Improperly inserting a tube for nasogastric or nasoenteric one can cause grave injury or even death.
Avanos Mediacal Cortrak 2 According to Avanos the number of incidents has been an estimated 60 injuries and 23 death in connection with this issue. Some of the adverse events reported were pneumothorax, respiratory failure perforation, pneumonia, as well as the development of pleural effusion.
This recall will be used to update Cortrak*2’s instructions for use, intended uses, and instruct users to confirm tube placement according to institutional protocols before using the tube to provide nutrition.
Clinicians were instructed to attach the relevant field correction notice in the operating manual. They should also return the acknowledgement form that came along with the Avanos notification. The company will soon be able to send out updated labeling to users, including confirmation of tube placement in accordance with the institutional guidelines.
Website: http://ezproxy.cityu.edu.hk/login?url=https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas
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