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Avanos Medical recalled Cortrak* 2 EAS following incidents of injury and deaths caused by tube malfunctions.
Avanos Mediacal Cortrak 2 The US Food and Drug Administration (FDA), has declared the recall of Avanos Medical of Cortrak*2 Ental Access System, (EAS) as a class I recall.
Cortrak 2 eternal access system The term "Class I Recall" is a reference to the most difficult of three classes.
Avanos Medical Avanos Medical has recalled Cortrak*2 EAS following reports of deaths or injuries caused by misplacements of nasogastric tubes.
The device was created to assist health care workers in placing medical feed tubes into patients.
Avanos Medical A wrong placement of the nasogastric and nasoenteric tube can cause serious injury , or even the death of a patient.
The company has now been able to recall 629 devices in the US that were sold between 1 April 2016 - 1 January 2022.
The company recall communication stated that 60 patients suffered injuries and 23 died due to incorrect placement in nasogastric tube while using Cortrak* 2 EAS.
Avanos Medical Avanos Mediacal Cortrak 2 Avanos Medical will revise the labelling following the recall. This includes updating Cortrak*2 EAS's instructions and intended uses.
Avanos Mediacal Cortrak 2 The updated guidelines also instruct users to confirm tube placement according to the institution's protocol prior to use.
Avanos Medical has its headquarters in Alpharetta Georgia. Its brands are sold in more than 90 countries.
https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding The company signed a $160m agreement in December of last year to acquire OrthogenRx. Avanos Medical concluded the acquisition on the 20th of January.
Website: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding
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