Bivona® Neonatal/Pediatric and Adult Tracheostomy Products
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected product |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Neonatal Tracheostomy Tube, Flextend Cuffless |
Contact manufacturer |
60NFP35 |
Neonatal Tracheostomy Tube, Mid Range Aire-Cuf |
Contact manufacturer |
65SN035 |
Pediatric Tracheostomy Tube, Cuffless |
Contact manufacturer |
60SP030 |
Neonatal Tracheostomy Tube, Cuffless |
Contact manufacturer |
60N035 |
Tracheostomy Tubes Mid-Range Aire-Cuf, Silicone, Adult |
Contact manufacturer |
750170 |
Tracheostomy Tubes Flextend, Pediatric, Wire Reinforced Silicone |
Contact manufacturer |
60PFSS45 |
Tracheostomy Tubes Tight To Shaft (Tts) Airecuf Silicone Adult |
Contact manufacturer |
670170 |
Pediatric/Neonatal Tracheostomy Tubes |
Contact manufacturer |
67P030 |
Pediatric Tracheostomy Tube, Mid Range Aire-Cuf |
Contact manufacturer |
65P025 |
Issue
Smiths Medical has identified that the securement flange of specific lots of the Bivona® neonatal/pediatric and adult tracheostomy products may tear because of a manufacturing defect.
Recall start date: May 24, 2024
Additional information
Details
| Smiths Medical Asd, Inc. |
| 6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442 |
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