Device product
Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
Z-1870-2017
Product summary
- Firm
- Cook Inc.
- Event
- Event 76927
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19756
- Official record key
device-enforcement:Z-1870-2017
Official wording
Reason: Product may overheat, melt, and burn patient.
Code information: All lots.
Distribution pattern: The devices have been distributed within the United States and the following countries: Bahamas, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Ireland, Israel, Italy, Jersey, Kuwait, Mexico, Morocco, New Zealand, Norway, Panama, Paraguay, Portugal, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Trinidad and Tobago, United Arab Emirates and the United Kingdom.
Derived failure modes
-
Unknown
Product may overheat, melt, and burn patient.