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This issue is responsible for at the very least 60 injuries and 23 fatalities.
This recall was identified by the FDA as an Class I recall. Avanos Medical feeding tube It is the most serious type of recall. Cortrak 2 eternal access system These devices could cause serious injury or even death.
Cortrak 2 eternal access system Sam Brusco Associates Editor05.16.22
The FDA has identified Avanos Medical's recall of their Cortrak*2 intramuscular access device. 629 devices, distributed between 2016 and 2022, were recalled by U.S. starting on March 21.
Cortrak 2 eternal access system Cortrak*2 assists clinicians in placing medical feed tubes into patients who require nutrition via the tube.
The system's recall was caused by the deaths and injuries of patients resulting from an error in placement of the nasocentric or nasogas. These tubes assist in insertion. A wrongly placed nasogastric or nasal tube can result in severe injury or death.
Avanos Medical feeding tube According to Avanos safety information, this issue has caused 60 injuries and 23 deaths. A variety of adverse events were reported such as respiratory failure, pneumonia and pneumothorax.
This recall will be used to update Cortrak*2’s instructions regarding use, intended usage and also remind users to confirm tube placement as per institutional guidelines prior to using the tube to deliver nutritional benefits.
Clinicians were also encouraged to attach the corrected note in the field on the issue to Avanos' operating manual, and to return the acknowledgment forms that came in Avanos' notice. Avanos Medical The company hopes to soon give users updated labeling. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its This includes confirmation that tube placement was done according to institutional policy.
Website: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its
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