Smiths Medical recalls Bivona — Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®,…
- Recall date
- September 4, 2024
- Source
- U.S. Food & Drug Administration (FDA) — recall announcement
- Brand / firm
- Smiths Medical, Bivona
Why it was recalled
The securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. — Defect
What was recalled
Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™ Adult Tracheostomy Tube(s)
Read the official recall notice →
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