Bivona Tracheostomy Tubes Recalled Due to Defective Securement Flange
Smiths Medical is recalling PORTEX Bivona Tracheostomy Silicone Tubes because the securement flange may tear due to a manufacturing defect. The defect affects multiple lot numbers across all size variants distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4. The manufacturing defect affecting the securement flange of a critical medical device used for airway management presents significant risk of harm despite no reported injuries to date.
Plain-English summary
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Silicone Tubes across six size variants: 3.0MM, 3.5MM, 4.0MM, 4.5MM, 5.0MM, and 5.5MM. These products are distributed worldwide for tracheostomy care in pediatric and adult patients.
A manufacturing defect may cause the securement flange to tear in the affected lots. The securement flange is the component that maintains the tube's position during use, and a tear could affect tube security.
The recall affects specific lot numbers identified by product code 60PFSS30, 60PFSS35, 60PFSS40, 60PFSS45, 60PFSS50, and 60PFSS55. Detailed lot numbers for each variant are available from the FDA and Smiths Medical for inventory verification.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Tracheostomy
- Hazard
- manufacturing-defect
- flange-tear
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) UDI/DI 15021312516760
- Product Code/List Number/Item Code 60PFSS30
- Lot Numbers: 3868215
- 3868216
- 3868217
- 3868218
- 3874311
- 3880720
- 3887755
- 3894894
- 3904669
- 3907971
- 3917982
- 3926967
- 3933476
- 3939635
- 3942492
- 3946278
- 3946279
- 3946280
Distribution
Distribution scope not specified by the agency.
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