Smiths Medical ASD Inc. recalls Bivona¿ Tracheostomy Tube Tracheostomy Tubes
- Recall date
- April 2, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2114-2018
- FDA classification
- Class II
- Brand / firm
- Smiths Medical ASD Inc.
- Sold / distributed
- Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.
Why it was recalled
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
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