Bivona Neonatal Tracheostomy Tubes recalled due to defective securement flanges
Smiths Medical recalls specific lots of PORTEX Bivona neonatal and pediatric tracheostomy tubes due to manufacturing defects in the securement flange that may tear.
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 classified this as a Class I recall, indicating a serious health hazard or possibility of death. The defective securement flange on a critical airway device poses significant risk to patients dependent on tracheostomy tubes. No deaths or injuries have been reported to date.
Plain-English summary
Smiths Medical has identified a manufacturing defect in the securement flange of specific lots of the PORTEX Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes (Product Code 67N040, UDI/DI 15021312006230). The defective flange may tear, potentially compromising the tube's ability to remain securely positioned in the patient's airway.
This recall affects patients with the following serial numbers: 3877658, 3901313, 3923737, 3936563, 3942521, 3965334, 4016051, 4331550, 4334880, 4352757, 4362870, 4369535, 4380068. The product has been distributed worldwide.
Patients who use affected tracheostomy tubes should contact their healthcare provider or Smiths Medical for guidance on replacement or corrective action.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
- 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 (15)
- UDI/DI 15021312006230
- Product Code/List Number/Item Code 67N040
- Serial Numbers: 3877658
- 3901313
- 3923737
- 3936563
- 3942521
- 3965334
- 4016051
- 4331550
- 4334880
- 4352757
- 4362870
- 4369535
- 4380068
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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