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Recall Observatory FDA recall evidence

Device product

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

Z-1870-2017

March 07, 2017

Class II

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

    reason.no_named_rule · v1.0.0

    Product may overheat, melt, and burn patient.