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.
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. 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 67NFPS
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- flange-tear
- device-failure
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.
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