Bivona Neonatal, Pediatric, and Adult Tracheostomy Tubes Recalled for Flange Defect
Smiths Medical is recalling specific lots of Bivona Neonatal, Pediatric, and Adult Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, potentially compromising tube security.
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, which indicates the defect poses a reasonable probability of serious adverse health consequences. The product is a critical airway management device used in vulnerable patient populations. Although no injuries or deaths have been reported, the nature of the defect—potential tearing of the securement component—in a life-critical application warrants a Severe classification.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of Bivona Neonatal, Pediatric, and Adult Tracheostomy Tubes due to a manufacturing defect. The securement flange on these devices may tear.
The recalled models include the 4.0MM FLEXTEND PLUS, 5.0MM FLEXTEND PLUS, and 5.5MM FLEXTEND PLUS tracheostomy tubes. These products have been distributed worldwide.
The securement flange is the component designed to hold the tracheostomy tube in place. A torn flange could affect the tube's ability to remain properly secured. Patients and healthcare providers should visually inspect affected tubes for tears or damage. If you have an affected product, contact your healthcare provider or Smiths Medical ASD Inc.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM…
- 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 15021312005806
- Product Code/List Number/Item Code 60PFP40
- Lot Numbers: 3868314
- 3874308
- 3880719
- 3887716
- 3887717
- 3901303
- 3907999
- 3918005
- 3918006
- 3942497
- 3946273
- 3946274
- 3955779
- 3962577
- 3982658
- 3997815
- 4001202
- 4015539
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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