Reported Sep 4, 2024 · Announced
Smiths Medical recalls Bivona Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless…
Smiths Medical
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.What you should do
Stop using the product and follow the return or refund instructions in the firm's announcement.
Is this the product you have?
- 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) BrandBivona. Medical Devices
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.
The agency has not ranked the risk yet — treat the notice as a caution.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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