Device product
Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
Z-0968-2020
Product summary
- Firm
- Cook Inc.
- Event
- Event 82026
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13388 total
- Official record key
device-enforcement:Z-0968-2020
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: NS8070854 8078209 8116743
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.