PORTEX Bivona Tracheostomy Tubes Recalled for Defective Securement Flange
Smiths Medical is recalling PORTEX Bivona neonatal and pediatric tracheostomy tubes worldwide due to a manufacturing defect in the securement flange that may tear and affect proper positioning.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 establishes a minimum severity score of 4. The manufacturing defect affects the securement mechanism of a critical airway device used in vulnerable neonatal and pediatric patients.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of PORTEX Bivona neonatal and pediatric tracheostomy silicone tubes. The affected products include multiple configurations distributed worldwide, with specific product codes and lot numbers detailed in the FDA recall notice.
The manufacturer has identified a manufacturing defect affecting the securement flange of the recalled tubes. The flange may tear, which could compromise the tube's ability to remain securely positioned.
This recall affects neonatal and pediatric patients who depend on these tracheostomy tubes for breathing. Patients and healthcare facilities should verify whether they have affected products by checking the lot numbers listed in the FDA recall notice. Affected tubes should be removed from use and replaced with unaffected alternatives.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY…
- Manufacturer
- Smiths Medical ASD Inc.
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 15021312000115
- Product Code/List Number/Item Code 60SN025
- Lot Numbers: 3853489
- 3868323
- 3955794
- 4006293
- 4035766
- 4066280
- 4089302
- 4134028
- 4173737
- 4322691
- 4327883
- 4353056
- b) UDI/DI 15021312000122. Product Code/List Number/Item Code 60SN030
- Lot Numbers: 3874310
- 3930032
- 3946244
- 3949032
- 3952375
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 28 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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