Device product
Medtronic DLP Vessel Cannula, Model Number REF 30000
Z-1316-2024
Product summary
- Event
- Event 94068
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4343 units
- Official record key
device-enforcement:Z-1316-2024
Official wording
Reason: Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
Code information: UDI/DI 20613994646211, Lot Numbers: 2023020890, 202305C126, 2023020889
Distribution pattern: US and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK
Derived failure modes
-
Labeling or packaging
incorrect labeling