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RAM Medical entered its guilty plea through Richard A. Mazon, 61, of Wayne, who formally admitted that the company introduced adulterated and misbranded medical devices into interstate commerce.
The company buys overstocked and discounted products from wholesalers and suppliers all over the world and resells them to distributors and end-users in the U.S. the government said.
Three years ago, RAM Medical purchased 420 boxes of surgical hernia mesh from Alpa Vision F.Z.E. in the United Arab Emirates, which had received it from M/S Medserve in Delhi, India, a federal complaint on file in U.S. District Court in Newark says. RAM also bought another 100 boxes directly from Medserve in September 2009, it says.
Mazon admitted that the mesh, which was ostensibly manufactured by Davol Inc., a subsidiary of C.R. Bard, was periodically sold and distributed to seven RAM Medical customers. He also admitted that several boxes sold between December 2008 and June 2009 included adulterated mesh that contained numerous microorganisms.
“RAM Medical also acknowledged that boxes the company distributed between October 2008 and January 2010 contained misbranded, counterfeit mesh,” the government said in an official release.
U.S. Attorney Paul Fishman said the company has agreed to make full restitution for the value of the adulterated and misbranded surgical hernia mesh to they buyers.
As a condition of probation, “it will undertake responsibility for the locating and destruction of all the counterfeit Davol Inc. mesh it imported,” he added.
Sentencing is scheduled for March 8.
Fishman credited special agents of the U.S. Food and Drug Administration (FDA), Office of Criminal Investigations for making the case, which was prosecuted by Assistant U.S. Attorney Scott B. McBride of the U.S. Attorney’s Office Healthcare and Government Fraud Unit.
CLICK HERE for the FDA’s warning about the counterfeit surgical mesh
Fishman said the warning is “of particular significance to health care professionals and their patients with surgical mesh implants as well as hospitals and surgical centers, operating room medical professionals and staff, and purchasing and risk managers.”
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