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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Tracheostomy
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.
Part of a larger recall action
This product is one of 28 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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