Medical Device Safety and Recalls: PENTAX Validates Reprocessing Instructions for ED-3490TK Video Duodenoscopes: FDA Safety Communication

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

Title: Medical Device Safety and Recalls: PENTAX Validates Reprocessing Instructions for ED-3490TK Video Duodenoscopes: FDA Safety Communication

Today the FDA issued the Safety Communication, “PENTAX Validates Reprocessing Instructions for ED-3490TK Video Duodenoscopes” to notify health care professionals that Pentax issued revised, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the original device labeling. The Safety Communication recommends facilities using Pentax’s ED-3490TK Video Duodenoscope train staff on the new instructions and implement them as soon as possible.

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