Endoscope Manufacturer to Pay $43 Million to Resolve Criminal Charges of Distributing Misbranded Medical Devices
- April 10, 2020
Pentax Medical Company has agreed to pay $43 million to resolve criminal charges based on the company’s decision to ship four types of endoscopes for 18 months without the proper Food and Drug Administration (FDA)-cleared instructions for use and the company’s failure to file timely reports of two infections associated with its endoscopes, the Department of Justice (DOJ) announced April 7.
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