Device product
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Z-0146-2025
Product summary
- Event
- Event 95181
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 27,971 units
- Official record key
device-enforcement:Z-0146-2025
Official wording
Reason: Uncertainty in the seal integrity of the sterile packaging.
Code information: UDI/DI 35019315022405, Lot Numbers: 4122013, 4130776, 4130777
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
Uncertainty in the seal integrity of the sterile packaging.