Smiths Medical ASD Inc. recalls smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
- Recall date
- July 18, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0146-2025
- FDA classification
- Class II
- Brand / firm
- Smiths Medical ASD Inc.
- Sold / distributed
- Worldwide distribution.
Why it was recalled
Uncertainty in the seal integrity of the sterile packaging.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
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