Device product
Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151
Z-0974-2020
Product summary
- Firm
- Cook Inc.
- Event
- Event 82026
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13388 total
- Official record key
device-enforcement:Z-0974-2020
Official wording
Reason: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Code information: 8011027 8183322 8037660 8030233 8018054 7994816
Distribution pattern: Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.
Derived failure modes
-
Unknown
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.