Avanos Medical to Pay $22 Million Settlement over Misbranded Surgical Gowns
Alpharetta, Ga.-based Avanos Medical has agreed to pay more than $22 million to resolve a criminal charge relating to the company’s alleged fraudulent misbranding of its MicroCool surgical gowns.
As part of the deferred prosecution agreement, the company admitted that between late 2014 and early 2015, it sold hundreds of thousands of MicroCool surgical gowns that were “labeled as AAMI Level 4 under the 2012 ANSI/AAMI PB70 standard but did not actually meet that standard,” the Department of Justice said.
The settlement was filed in the U.S. District Court for the Northern District of Texas, charging Avanos with introducing misbranded surgical gowns into interstate commerce with the intent to defraud and mislead. According to the legal documents, Avanos falsely labeled the gowns as providing the highest level of protection against fluid and virus penetration.