Recall Z-2540-2017 ยท FFS Image, Illumination, Fiberoptic, For Endoscope
Cook Inc.
Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
| Date | Jun 5, 2017 (initiated May 3, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Cook Inc. initiated a voluntary recall of multiple products because it was identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. Potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. Notices were mailed on 05/9/2017 via courier. Customers were asked to do the following: Distribution of the VueOptic Visualization S |
| Quantity | 1328 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH Cook Urological, Inc., Nov 20, 2007 |