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This issue is responsible for at least 60 injuries and 23 fatalities.
This is an item classified as a Class I recall issued by FDA which is the most serious type. The devices could cause serious injuries, or even death.
Avanos Mediacal Cortrak 2 Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical as the one responsible for recalling its Cortrak*2 system of access to the enteral. 629 devices distributed between 2016 to 2022 were recalled within the U.S., beginning on March 21.
Cortrak*2 permits clinicians to insert medical feeding tubes into the stomach or small bowel of patients who require nutrition.
This recall was initiated because of reports of injuries and death in patients following mistakes in the placement of gastric or nasocentric tubes. https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges feeding tube placement The device is used to place the tubes. Avanos Mediacal Cortrak 2 https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding An error in inserting an Nasogastric tube or Nasoenteric one can cause serious injury or death.
According to AvanosSafety Communication the number of deaths was 60 and 23 injuries related to the issue. The adverse events mentioned included respiratory failure, perforation, pneumonia, in addition to pleural effusion.
Cortrak*2 is using this recall to revise the guidelines for use and intended uses. The users will have to confirm the proper placement of tubes in accordance with institutional protocols, before they can be used to provide nutrition.
Avanos Medical Clinicians were also advised to attach the amended field notice on the issue to Avanos operating manual and to return the acknowledgment forms that came with Avanos announcement. The company is expected to be able to send out updated labeling for users, which will include confirmation of tube placement as per institutional policies.
Avanos Mediacal Cortrak 2
Homepage: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding
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