Device product
Endotine Transbleph 3.5 (CFD-080-0167)
Z-2294-2016
Product summary
- Event
- Event 74222
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29
- Official record key
device-enforcement:Z-2294-2016
Official wording
Reason: MicroAire has initiated a limited recall (29 Units)on the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373, due to minor mislabeling ( the front label is correct, but the side label lists an incorrect part number, i.e. CFD-080-0177).
Code information: Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373
Distribution pattern: The product was distributed in the United States and Sweden
Derived failure modes
-
Labeling or packaging
mislabeling