PORTEX Bivona Tracheostomy Tubes Recalled for Flange Tearing Defect
Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, risking loss of airway securement.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, the highest severity classification. The manufacturing defect directly affects airway securement in neonatal and pediatric patients, creating serious risk of tube displacement and breathing compromise.
Plain-English summary
Smiths Medical is recalling PORTEX Bivona Neonatal, Pediatric, and Adult Tracheostomy Silicone Tubes in multiple sizes (2.5, 3.0, 3.5, and 4.0 FlexTend Plus models). These tubes are used to establish and maintain airways in patients with tracheostomies.
The company identified that the securement flange of specific lots may tear due to a manufacturing defect. The securement flange is essential for keeping the tube properly positioned during use.
The affected products have been distributed worldwide. The recall includes specific product codes (60NFP25, 60NFP30, 60NFP35, 60NFP40) and their associated serial numbers.
Patients and healthcare providers using these devices should contact Smiths Medical or their healthcare provider for guidance regarding affected products.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- flange-tearing
- manufacturing-defect
- airway-obstruction
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 15021312014716
- Product Code/List Number/Item Code 60NFP25
- Serial Numbers: 3939632
- 3942500
- 4016061
- 4204813
- 4334983
- 4348458
- b) UDI/DI 15021312014723
- Product Code/List Number/Item Code 60NFP30
- Serial Numbers: 3868231
- 3877660
- 3884269
- 3894895
- 3907972
- 3917986
- 3927831
- 3939639
- 3949048
- 3955816
Distribution
Distribution scope not specified by the agency.
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