FDA-Device2017-04-26Class II

Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set

Cook Inc.
Hazard

Product may overheat, melt, and burn patient.

Sold states
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.
Affected count
19756
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1870-2017

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