Bivona® Neonatal/Pediatric and Adult Tracheostomy Products
Brand(s)
Last updated
Summary
Product
Bivona® Neonatal/Pediatric and Adult Tracheostomy Products
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected product | Lot or serial number | Model or catalogue number |
|---|---|---|
| Neonatal Tracheostomy Tube, Flextend Cuffless | Contact manufacturer | 60NFP35 60NFPS30 60NFP30 60NFPS25 60NFPS35 60NFPS40 |
| Neonatal Tracheostomy Tube, Mid Range Aire-Cuf | Contact manufacturer | 65SN035 65N040 65N030 65N035 65SN030 |
| Pediatric Tracheostomy Tube, Cuffless | Contact manufacturer | 60SP030 60P050 60P045 60SP040 60P025 60P035 60P040 60P030 60P055 60SP025 60SP035 60SP050 60SP055 60SP045 |
| Neonatal Tracheostomy Tube, Cuffless | Contact manufacturer | 60N035 60N025 60N030 60N040 60SN025 60SN030 60SN035 60SN040 |
| Tracheostomy Tubes Mid-Range Aire-Cuf, Silicone, Adult | Contact manufacturer | 750170 750180 750160 |
| Tracheostomy Tubes Flextend, Pediatric, Wire Reinforced Silicone | Contact manufacturer | 60PFSS45 60PFSS50 67PFP55 67PFSS40 60PFSS55 67NFPS25 67PFP40 67PFPS60 67PFSS55 60PFPS40 60PFS40 67PFP45 67PFSS30 67PFSS35 67PFSS50 60PFPS45 60PFSS30 67PFPS40 67PFPS45 60PFPS50 60PFS35 60PFS45 67NFPS40 67PFP60 67PFPS55 67PFSS45 60PFP40 60PFPS60 60PFSS35 60PFSS40 67NFPS30 67NFPS35 67PFPS50 60PFSS25 67PFS35 67PFS40 60PFS50 60PFS55 |
| Tracheostomy Tubes Tight To Shaft (Tts) Airecuf Silicone Adult | Contact manufacturer | 670170 670180 |
| Pediatric/Neonatal Tracheostomy Tubes | Contact manufacturer | 67P030 67SN040 67SP025 67SP050 67N040 67SP045 67SP055 67P045 67P055 67P040 67SN030 67N025 67SN035 67N035 67SN025 67SP030 67N030 67SP035 67SP040 67P035 67P050 |
| Pediatric Tracheostomy Tube, Mid Range Aire-Cuf | Contact manufacturer | 65P025 65P030 65P045 65P050 65SP035 65SP045 65P040 65P035 |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
| Smiths Medical Asd, Inc. |
| 6000 Nathan Lane N., Minneapolis, Minnesota, United States, 55442 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-75610
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