July 8, 2021

Medical supply company Avanos Medical Inc. entered into a deferred prosecution agreement and will pay $22.2 million to resolve charges that it sold misbranded surgical gowns, labeling the MicroCool gowns as providing the highest level of fluid and virus protection under ANSI/AAMI standards, when the company knew the gowns had never met that standard.  The government also alleged that Avanos obstructed FDA inspection efforts.  ND Tex

Tagged in: Criminal Proceedings, FDA Fraud, Medical Devices and DME,