Device product
Stamey Needle
Z-2536-2017
Product summary
- Firm
- Cook Inc.
- Event
- Event 77217
- Status
- Terminated
- Classification
- Class II
- Quantity
- 698
- Official record key
device-enforcement:Z-2536-2017
Official wording
Reason: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Code information: All lots Catalog numbers: 095000; 095015; 095030; J-SYN-931600; J-SYN-931615; J-SYN-931630
Distribution pattern: The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
Derived failure modes
-
Unknown
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products