Device product
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS
Z-1465-2023
Product summary
- Firm
- Covidien LP
- Event
- Event 92004
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 units
- Official record key
device-enforcement:Z-1465-2023
Official wording
Reason: There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
Code information: UDI-DI: 10884521784062; Serial Numbers: C21RXG0005
Distribution pattern: Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
Derived failure modes
-
Foreign material or chemical contamination
metal shaving