Medical device recalls

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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