Sep 042024
Date |
Brand Name(s) |
Description |
Type |
Reason |
Company |
| 9/4/2024 | Bivona | 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) | Medical Devices | The securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | Smiths Medical |
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