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Avanos Medical pulled Cortrak*2 EAS from service after receiving reports of injuries and deaths due to tube missing.
The US Food and Drug Administration (FDA) has declared the recall issued by Avanos Medical of Cortrak*2 Ental Access System, (EAS), as an I class recall.
A Class I recall is a reference to the most severe of three classes.
Avanos Medical has recalled Cortrak*2 EAS following reports of injuries or deaths caused by misplacements of nasogastric tubes.
The device is able to assist health care professionals in placing medical feeding tubes into patients. Avanos Mediacal Cortrak 2 It also provides real-time information regarding tube placement.
https://setiweb.ssl.berkeley.edu/beta/show_user.php?userid=10228813 Incorrect placement of nasogastric and nasoenteric tube can result in serious injuries or the death of a patient.
https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ The company is recalling 629 units, which were sold across the US from April 1st, 2016 until 1 January 2022.
The notice of recall issued by the company also stated that there were 60 injuries and 23 deaths in patients since 2015 due to the misplacement or misplacement the nasogastric feeding tubes when using the Cortrak* 2 EAS.
Avanos Medical, following the recall, will update the device’s labelling. feeding tube placement Avanos Mediacal Cortrak 2 This will include updated instructions regarding the use and intended uses of Cortrak*2 EAS.
Revisioned guidelines require that users confirm the location of tubes based on protocols of their institutions before using the tubes.
Cortrak 2 eternal access system Headquartered in Alpharetta, Georgia, US, Avanos Medical focuses on the production of medical devices that are clinically proven. The brand's name is accessible in over 90 countries.
https://lexsrv3.nlm.nih.gov/fdse/search/search.pl?match=0&realm=all&terms=https://content.govdelivery.com/accounts/USFDA/bulletins/317bc54 In December, the company entered into an agreement of $160 million to acquire OrthogenRx. Avanos Medical closed on the acquisition in January.
Here's my website: https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/
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