Medical Device Safety and Recalls: UPDATE - Importance of Following Validated Reprocessing Instructions for PENTAX ED-3490TK Video Duodenoscopes: FDA Safety Communication

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: UPDATE - Importance of Following Validated Reprocessing Instructions for PENTAX ED-3490TK Video Duodenoscopes: FDA Safety Communication

The Food and Drug Administration issued a Safety Communication to inform users about a design issue with the PENTAX ED-3490TK duodenoscope that could increase the risk of patient infection. This safety communication contains updated recommendations to help prevent the spread of infection associated with the use of these devices.

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