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FDAMay 3, 2017device

Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

What to do

FDA enforcement status: Terminated

Brands named

cook

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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