Device product
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
Z-0145-2025
Product summary
- Event
- Event 95181
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9,133 units
- Official record key
device-enforcement:Z-0145-2025
Official wording
Reason: Uncertainty in the seal integrity of the sterile packaging.
Code information: UDI/DI 35019315011003, Lot Numbers: 4131841, UDI/DI 35019315022405, Lot Numbers: 4122012, 4133227
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
Uncertainty in the seal integrity of the sterile packaging.