PORTEX Bivona Neonatal and Pediatric Tracheostomy Tubes Recalled for Flange Tear
Smiths Medical is recalling specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes because the securement flange may tear due to a manufacturing defect.
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: FDA Class I medical device recall affecting critical airway management equipment. The manufacturing defect affecting the securement flange represents a real safety hazard, though no incidents have been reported in the available source material.
Plain-English summary
Smiths Medical is recalling specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes. The manufacturer has identified a manufacturing defect that may cause the securement flange to tear.
The affected products include multiple size variants of neonatal and pediatric tubes, distributed worldwide. Specific affected lot numbers are identified and listed by product code.
Patients using these devices and their healthcare providers should verify whether their tracheostomy tube is among the recalled lots. Healthcare facilities should review their stock and consult with the manufacturer or FDA for guidance on appropriate clinical action.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL…
- 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 15021312000238
- Product Code/List Number/Item Code 67SN025
- Lot Numbers: 3897849
- 3936582
- 4016050
- 4119116
- 4176209
- 4328223
- 4334976
- 4352775
- 4365802
- b) UDI/DI 15021312000245
- Product Code/List Number/Item Code 67SN030
- Lot Numbers: 3868317
- 3877644
- 3897881
- 3908000
- 3965329
- 3965330
- 4080793
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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