Device product
Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22MM X 90MM, resterilized.
Z-3038-2018
Product summary
- Event
- Event 80317
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units total
- Official record key
device-enforcement:Z-3038-2018
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 6559-R; Lot Number 17252887 (Serial Number 16211282016-02); Lot Number 17465176 (Serial Numbers 97403172017-16, 97403172017-40)
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.