Device product
Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
Z-1427-2013
Product summary
- Event
- Event 65083
- Status
- Terminated
- Classification
- Class II
- Quantity
- NA
- Official record key
device-enforcement:Z-1427-2013
Official wording
Reason: Clarification of existing labeling information and operating procedures.
Code information: Model number 420002-07
Distribution pattern: Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.
Derived failure modes
-
Unknown
Clarification of existing labeling information and operating procedures.