FDA-Device2024-10-30Class II
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Smiths Medical ASD Inc.
Hazard
Uncertainty in the seal integrity of the sterile packaging.
Sold states
Worldwide distribution.
Affected count
27,971 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0146-2025Don't want to check this manually?
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