FDA recall Z-0146-2025
Smiths Medical ASD Inc. · Class II · device
Product
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Reason for recall
Uncertainty in the seal integrity of the sterile packaging.
Distribution
Worldwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2024-07-18
- Report date
- 2024-10-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Minneapolis, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0146-2025