PORTEX Bivona Tracheostomy Tubes Recalled for Securement Flange Manufacturing Defect
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. Products distributed worldwide.
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 of a critical airway medical device. Per the severity rubric, FDA Class I recalls receive a minimum severity score of 4 (Severe), reflecting the agency's determination that the manufacturing defect poses a serious potential health hazard.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of PORTEX Bivona Tracheostomy Tubes, which are available in neonatal, pediatric, and adult models in sizes 2.5mm through 5.5mm (uncuffed). These products have been distributed worldwide.
The securement flange on affected units may tear because of a manufacturing defect. The securement flange is designed to hold the tube in place within the patient's airway. Specific lot numbers for each product size are identified in the FDA recall notice.
The FDA has classified this as a Class I recall, indicating a serious potential health hazard. Healthcare providers and patients who may have received affected units should verify lot numbers against the official FDA recall notice Z-2595-2024 and contact their healthcare provider regarding affected products.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , P
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Tracheostomy
- Hazard
- manufacturing-defect
- flange-tear
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 15021312005721
- Product Code/List Number/Item Code 60P025
- Lot Numbers: 3880717
- 3901307
- 3939666
- 3955786
- 3991203
- 4015575
- 4035758
- 4083928
- 4110465
- 4156650
- 4176238
- 4209581
- 4226268
- 4254269
- 4331631
- 4335055
- 4345041
- 4348782
Distribution
Distribution scope not specified by the agency.
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