Device product
The UNI-CP System; Model Number: 330230SND.
Z-1410-2017
Product summary
- Event
- Event 76408
- Status
- Terminated
- Classification
- Class III
- Quantity
- 39 units
- Official record key
device-enforcement:Z-1410-2017
Official wording
Reason: The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.
Code information: Lot # FEDT
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
label on the UNI-CP plate was incorrect