Smiths Medical Issues Urgent Medical Device Notification Informing Customers of a Potential Issue with Certain Bivona® Tracheostomy Tubes
- Date
- Aug 19, 2024
- Company
- Smiths Medical
- Brand
- Bivona
- Product
- 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)
- Reason
- The securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
- Hazard
- Other
- Source
- FDA
Facts are taken from the official notice. If anything here differs from it, the official notice is correct.