Z-2540-2017 Class II Terminated
FDA device recall Z-2540-2017 was initiated by Cook Inc. on May 3, 2017 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated January 26, 2018). Affected quantity: 1328 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 3, 2017
- Termination Date
- January 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1328 units
Product Description
Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
Reason for Recall
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.
Distribution Pattern
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
Code Information
Vue Optic Visualization Source, Catalog Number: FVO-150, GPN: G25343 Flexor Vue Deflecting Endoscopic System Catalog Number: FV-090075-150, GPN: G50972 Catalog Number: FV-090045-150, GPN: G34306