Smiths Medical ASD Inc. recalls Pediatric Adjustable Flange Tracheostomy Tube Cuffless
- Recall date
- May 26, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2485-2020
- FDA classification
- Class II
- Brand / firm
- Smiths Medical ASD Inc.
- Sold / distributed
- U.S: NE, TN, TX, and MS. Worldwide: France, Sweden, United Arab Emirates, UK, Netherlands, Czechia, Australia and Denmark.
Why it was recalled
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
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