Manhattan U.S. Attorney Settles Civil Fraud Claims Against Medical Device Distributor For Selling Products Not Approved By The FDA

Geoffrey S. Berman, the United States Attorney for the Southern District of New York, and Jeffrey E. Shuren, M.D., director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration ("FDA"), announced today that the U.S. has settled civil fraud claims under the False Claims Act against CAREFUSION CORPORATION ("CAREFUSION"), a medical device distributor based in San Diego, California, for buying and selling medical devices that were not approved or cleared by the FDA. These unapproved and uncleared devices were then used by medical providers in medical procedures, and the providers submitted claims for reimbursement to federal healthcare programs, such as Medicare and Medicaid, for those procedures.

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