Fayette County

Woman sold unauthorized surgical supplies to University of Kentucky hospital

UK Chandler Hospital in Lexington, Ky.
UK Chandler Hospital in Lexington, Ky. Herald-Leader

A Florida woman has admitted selling to University of Kentucky Chandler Hospital surgical supplies that weren’t supposed to be exported to the United States.

Janaina Nascimento faces up to a year in prison when she is sentenced in March.

Nascimento, of Miami, operated a company called Lion Heart Surgical Supply LLC. In January 2019, she bought 70 boxes of materials that the seller said was a sterile absorbable hemostat, according to a court document.

Hemostats are used during surgery to control bleeding.

Nascimento’s company bought the boxes from a company in the United Arab Emirates, according to a court document.

Nascimento sold the hemostats to another distributor in February 2019, but that company returned them, telling Nascimento they weren’t authorized for distribution in the United States.

The customer showed Nascimento a label on the product that said, “NOT FOR RE-EXPORT TO THE U.S.A.” But Nascimento disagreed, saying the product had been legally imported, according to a court document.

Nascimento later sold the hemostats to another company in Florida but removed the warning label before shipping them.

That company sold the hemostats to the UK hospital in April 2019.

After surgeons complained about the hemostats, an investigation showed they were a counterfeit product made in a facility not registered with the U.S. Food and Drug Administration, according to Nascimento’s plea agreement.

She pleaded guilty Monday in federal court in Lexington.

Bill Estep
Lexington Herald-Leader
Bill Estep covers Southern and Eastern Kentucky. Support my work with a digital subscription
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