Device product
Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
Z-3028-2018
Product summary
- Event
- Event 80317
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units total
- Official record key
device-enforcement:Z-3028-2018
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 EZC24A-R; Lot Number 59634962; Serial Numbers 16401032017-01, 16401032017-02, 16401032017-03, 16401032017-04, 16401032017-05, 16401032017-06, 16401032017-07, 16401032017-08, 16401032017-09, 16401032017-10, 16401032017-11, 16401032017-12, 16401032017-13, 16401032017-14, 16401032017-15, 16401032017-16, 16401032017-17, 16401032017-18, 16401032017-19, 16401032017-20, 16401032017-21, 16401032017-22, 16401032017-23, 16401032017-24, 16401032017-25, 16401032017-26, 16401032017-27, 16401032017-28, 16401032017-29, 16401032017-30, 16401032017-31, 16401032017-32, 16401032017-33, 16401032017-34, 16401032017-35, 16401032017-36, 16401032017-37
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.