PORTEX Bivona Tracheostomy Tubes Recalled Due to Flange Tearing Defect
PORTEX Bivona Tracheostomy Tubes (3.0mm, 3.5mm, 4.0mm) are being recalled due to a manufacturing defect that may cause the securement flange to tear. This could result in airway obstruction or loss of tube securement.
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 score of 4. While no deaths or reported illnesses are documented in the source, the manufacturing defect affecting the securement flange of tracheostomy tubes—critical airway management devices—poses a serious risk of airway obstruction or tube displacement in vulnerable patient populations.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of PORTEX Bivona Tracheostomy Silicone Tubes across multiple sizes: 3.0mm (Product Code 60NFPS30), 3.5mm (Product Code 60NFPS35), and 4.0mm (Product Code 60NFPS40). The recall affects 36,219 units distributed worldwide, including both neonatal/pediatric and adult formulations.
The recall was initiated because a manufacturing defect has been identified in the securement flange of affected units. The flange may tear during normal use, potentially resulting in loss of tube securement or displacement of the tracheostomy tube.
Patients with tracheostomies and healthcare providers using these products should immediately stop using affected units and consult with their healthcare provider about replacement options. The product is used in neonatal, pediatric, and adult patients who require tracheostomy tubes for airway management. Patients and providers can identify affected units by checking the product code and lot number on the FDA recall notice.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH T
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- flange-tear
- airway-obstruction
- aspiration-risk
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 15021312516685
- Product Code/List Number/Item Code 60NFPS30
- Lot Numbers: 3853441
- 3868206
- 3868207
- 3871067
- 3877651
- 3887742
- 3897854
- 3904673
- 3907995
- 3926957
- 3930007
- 3939665
- 3942472
- 3946282
- 3946283
- 3955764
- 3962605
- 3982653
Distribution
Distribution scope not specified by the agency.
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