Device product
Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding Stent, 10MM X 94MM | 135CM, resterilized.
Z-3040-2018
Product summary
- Event
- Event 80317
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units total
- Official record key
device-enforcement:Z-3040-2018
Official wording
Reason: The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Code information: Code Number 71139-R; Lot Numbers 17752073, 17752073, 17422520; Serial Numbers 21408032017-03, 21408032017-04, 21408032017-05
Distribution pattern: US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
Derived failure modes
-
Unknown
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.