FDAFDA · Food and drugs·Recall number Z-0146-2025
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Published October 30, 2024 · Recall initiated: July 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Uncertainty in the seal integrity of the sterile packaging.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- Worldwide distribution.
- Lot
- UDI/DI 35019315022405, Lot Numbers: 4122013, 4130776, 4130777
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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