Bivona Neonatal Tracheostomy Tubes Recalled for Flange Tear Risk
Smiths Medical is recalling specific lots of Bivona Neonatal and Pediatric Tracheostomy Tubes because the securement flange may tear due to manufacturing defects.
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: FDA Class I classification mandates a minimum severity of Severe per the rubric rules. The defect affects a critical airway securement device used in neonates and pediatric patients. Although no deaths or injuries have been reported, the structural defect poses significant risk.
Plain-English summary
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect affecting the securement flange. The affected neonatal sizes listed include 2.5mm, 3.0mm, 3.5mm, and 4.0mm products, identified by specific serial numbers provided in the recall notice.
The securement flange of the affected tubes may tear. The flange is the component designed to hold the tube securely in place.
The affected units have been distributed worldwide. Patients, particularly neonates and pediatric patients, may be at risk if using recalled tubes.
Users should verify their device serial numbers against the recall list. Discontinue use of affected tubes and contact Smiths Medical for replacement or further guidance.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- manufacturing-defect
- securement-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 10351688518736
- Product Code/List Number/Item Code 67NFP25
- Serial Numbers: 3936586
- 4033699
- 4091401
- 4334881
- b) UDI/DI 10351688518743
- Product Code/List Number/Item Code 67NFP30
- Serial Numbers: 3853379
- 3864236
- 3874314
- 3884252
- 3901302
- 3930043
- 3955792
- 3962588
- 3997790
- 4011356
- 4033700
- 4063161
Distribution
Distribution scope not specified by the agency.
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