Device product
smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS
Z-0144-2025
Product summary
- Event
- Event 95181
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 34,141 units
- Official record key
device-enforcement:Z-0144-2025
Official wording
Reason: Uncertainty in the seal integrity of the sterile packaging.
Code information: a) REF 100/255/150, UDI/DI 35019315022399, Lot Numbers: 4125006; UDI/DI 35019315010990, Lot Numbers: 4159808, 4161750; UDI/DI 35019315011003, Lot Numbers: 4131840; UDI/DI 35019315018156, Lot Numbers: 4131559; UDI/DI 35019315022405, Lot Numbers: 4122011, 4127688; b) REF 100/255/150JP, UDI/DI 35019315010990, Lot Numbers: 4089148, 4107293, 4122008, 4147817, 4138707, 4159808; c) REF 100/255/150 JS, UDI/DI 35019315010990, Lot Numbers: 4122008, 4147817, 4159808
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
Uncertainty in the seal integrity of the sterile packaging.