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Smiths Medical ASD Inc. recalls smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Recalled October 30, 2024 · FDA recall Z-0146-2025 · Smiths Medical ASD
Hazard
Uncertainty in the seal integrity of the sterile packaging. · FDA Class II
Units
27,971 units
Sold at
Worldwide distribution.
Description
Uncertainty in the seal integrity of the sterile packaging.
Product
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Manufacturer(s)
Smiths Medical ASD Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →