PORTEX Bivona Neonatal Tracheostomy Tubes May Tear Due to Manufacturing Defect
Smiths Medical is recalling specific lots of PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear, affecting device 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. Per the severity rubric, FDA Class I medical device recalls mandate a minimum severity score of 4 (Severe). No deaths, injuries, or illnesses have been reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of the PORTEX Bivona Neonatal Tracheostomy Silicone Tubes in sizes 2.5mm, 3.0mm, 3.5mm, and 4.0mm with TTS FLEXTEND STRAIGHT FLANGE configuration. These medical devices maintain open airways in neonatal and pediatric patients requiring respiratory support.
The manufacturer identified a manufacturing defect affecting the securement flange of units in the affected lots. The flange may tear, which could compromise the device's ability to remain securely positioned.
The affected devices have been distributed worldwide. The recall includes specific lot numbers for each tube size, identified by product code and UDI-DI number.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , 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 10351688518774
- NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE
- Product Code/List Number/Item Code 67NFPS25
- Lot Numbers: 3853382
- 3880680
- 3901286
- 3918017
- 3930028
- 3952395
- 3961751
- 3997791
- 4026686
- 4038940
- 4038941
- 4096846
- 4113104
- 4136119
- 4151050
- 4159960
- 4171573
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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Same hazard · flange tear
See all →- SeverePORTEX Bivona Tracheostomy Tubes Recalled Due to Flange Tearing Defect
FDA (Devices) · 2024-09-04
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