Pentax Medical Devices Carry Infection Risk, FDA Says

Law360, New York (January 18, 2017, 3:05 PM EST) -- The U.S. Food and Drug Administration on Tuesday updated safety information for a video tube made by Pentax Medical, warning cracks and gaps in the device can lead to an increased risk of infection.

The adhesive seals on part of Pentax’s ED-3490TK video duodenoscope can crack or gap, which can make it easier for fluids or microbes to break through. As that part of the device is difficult to clean and disinfect properly, the risk of infection can increase, the agency said.

“Pentax is working closely with the FDA to further evaluate and mitigate the potential risk of infection associated with...

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