Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Flange Defect
Smiths Medical is recalling specific lots of Bivona tracheostomy tubes because the securement flange may tear due to a manufacturing defect.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which corresponds to a Critical severity score of 5 according to the rubric.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of PORTEX Bivona Tracheostomy Silicone Tubes. The affected products include Pediatric Tracheostomy Tubes in sizes 4.0mm, 4.5mm, 5.0mm, 5.5mm, and 6.0mm, identified by specific product codes and lot numbers listed in the recall notice.
The recall was initiated because the securement flange of these specific lots may tear due to a manufacturing defect. The agency has classified this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The affected products were distributed worldwide. Consumers and healthcare providers should stop using the affected lots and contact Smiths Medical for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45…
- 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 10351688518491
- Product Code/List Number/Item Code 67PFP40
- Lot Numbers: 3868327
- 3880710
- 3918015
- 3930013
- 3942484
- 3952350
- 4035694
- 4096834
- 4134018
- 4185407
- 4240126
- 4334895
- 4348414
- 4388111
- b) UDI/DI 10351688518507
- Product Code/List Number/Item Code 67PFP45
- Lot Numbers: 3864223
- 3880709
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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