Smiths Medical Bivona Neonatal Tracheostomy Tubes Recalled for Flange Tear
Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to manufacturing defect that may cause securement flange to tear, compromising tube stability.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I is the regulatory classification for serious health hazards or death risk, which corresponds to Critical severity per the rubric. A manufacturing defect affecting the securement mechanism of a neonatal tracheostomy tube represents a serious health hazard in a critical life-support application.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lot numbers of the PORTEX Bivona Neonatal Tracheostomy Silicone Tubes due to a manufacturing defect. The securement flange on affected units may tear, potentially compromising the tube's securement.
The recall affects three product codes (67N025, 67N030, 67N035) with specific lot numbers identified for each. The affected products have been distributed worldwide.
Patients and healthcare providers should verify whether their devices match the affected product codes and lot numbers identified by the manufacturer.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code…
- 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 15021312006209
- Product Code/List Number/Item Code 67N025
- Lot Numbers: 3894899
- 3949047
- 4011355
- 4139007
- 4153599
- 4185400
- 4327887
- 4331545
- 4334876
- 4352755
- 4353076
- 4372094
- 4388097
- 4400622
- b) UDI/DI 15021312006216
- Product Code/List Number/Item Code 67N030
- Lot Numbers: 3853378
- 3868286
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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