PORTEX Bivona Neonatal Tracheostomy Tubes recalled for defective securement flange
Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect in the securement flange, which may tear. Affected patients should discontinue use and contact their healthcare provider.
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: FDA Class I classification mandates a minimum score of 4. Although no illnesses or injuries have been reported, the defect affects a critical airway device used in neonatal patients, creating significant risk of harm.
Plain-English summary
Smiths Medical is recalling specific lots of PORTEX Bivona Neonatal Tracheostomy Tubes due to a manufacturing defect affecting the securement flange. The affected products include model codes 60N030, 60N035, and 60N040, distributed worldwide, with specific serial numbers identified for each variant.
The securement flange may tear because of a manufacturing defect. The securement flange is the component that secures the tracheostomy tube to the patient's neck.
Patients or caregivers using one of the affected tracheostomy tubes should discontinue use immediately and contact their healthcare provider for a replacement or alternative. Your provider can determine if your unit is affected based on the product code and serial number listed in the recall.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;
- Manufacturer
- Smiths Medical ASD Inc.
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 15021312005691
- Product Code/List Number/Item Code 60N030
- Serial Numbers: 3853477
- 3868292
- 3877665
- 3884248
- 3904659
- 3930047
- 3949025
- 3952381
- 3955770
- 3965339
- 3965340
- 4006289
- 4051641
- 4066298
- 4080798
- 4089297
- 4110464
- 4128036
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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