Device product
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Z-2249-2023
Product summary
- Event
- Event 92608
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 194 units
- Official record key
device-enforcement:Z-2249-2023
Official wording
Reason: Three lots of product may be labeled with an incorrect expiration day
Code information: UDI/DI 05391526210000, Lot Numbers: 1V00099635, 1V00166928, 1V00199622
Distribution pattern: US Nationwide distribution in the state of AZ.
Derived failure modes
-
Unknown
Three lots of product may be labeled with an incorrect expiration day