Device product
Vascular Solutions Venture Rx Catheter, 6F, resterilized.
Z-3041-2018
Product summary
- Event
- Event 80317
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units total
- Official record key
device-enforcement:Z-3041-2018
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 5820-R; Lot Number 570183 (Serial Number 99804132016-07); Lot Number 583022 (Serial Number 17304202017-07, 17304202017-08)
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.