Z-1870-2017 Class II Terminated
FDA device recall Z-1870-2017 was initiated by Cook Inc. on March 7, 2017 and is designated Class II. Reason for recall: Product may overheat, melt, and burn patient. The recall status is terminated (terminated October 16, 2018). Affected quantity: 19756.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2017
- Initiation Date
- March 7, 2017
- Termination Date
- October 16, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19756
Product Description
Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
Reason for Recall
Product may overheat, melt, and burn patient.
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.
Code Information
All lots.