Device product
Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.
Z-3032-2018
Product summary
- Event
- Event 80317
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit total
- Official record key
device-enforcement:Z-3032-2018
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 VFEM018-R; Lot Number 59740463; Serial Number 16704192017-01
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.