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Cook Inc. recalls Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by
Recalled June 21, 2017 · FDA recall Z-2540-2017 · Cook
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. · FDA Class II
Units
1328 units
Sold at
Domestic: FL IN LA MS NC TX Foreign:Argentina, Australia, Brazil, Canada, Czech Republic, Egypt, Estonia, France, Germany, Israel, Italy, Netherlands, Norway, Paraguay, Poland, Portugal, Russian Federation, Spain, Switzerland, Tunisia, Turkey, United Kingdom, VA/DOD:None
Description
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.
Product
Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
Manufacturer(s)
Cook Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →