Tracheostomy Tube Recall: PORTEX Bivona Due to Manufacturing Defect in Securement Flange
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because of a manufacturing defect that may cause the securement flange to 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 Class I classification with confirmed manufacturing defect affecting the securement flange. Per the rubric, Class I recalls cannot be scored below 4.
Plain-English summary
Smiths Medical is recalling specific lots of the PORTEX Bivona Neonatal/Pediatric Tracheostomy Silicone Tubes due to a manufacturing defect affecting the securement flange. The affected product code is 60PFSS25.
The securement flange of tubes in the affected lots may tear due to the manufacturing defect. The affected lot numbers are: 3868303, 3894869, 3949045, 3991182, 3997819, 4038948, 4075236, 4086044, 4148027, 4163850, 4185425, 4223732, 4234640, 4327882, 4352790, 4362855, and 4389906.
These tubes have been distributed worldwide. This is an FDA Class I recall.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Product Code/List Number/Item Code 60PFSS25
- 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 (18)
- UDI/DI 15021312516753. Product Code/List Number/Item Code 60PFSS25
- Lot Numbers: 3868303
- 3894869
- 3949045
- 3991182
- 3997819
- 4038948
- 4075236
- 4086044
- 4148027
- 4163850
- 4185425
- 4223732
- 4234640
- 4327882
- 4352790
- 4362855
- 4389906
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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