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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- manufacturing-defect
- flange-tear
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.
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