Bivona Tracheostomy Tubes Recalled for Manufacturing Defect in Securement Flange
Smiths Medical recalls specific lots of Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes worldwide due to 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 requires a minimum severity score of 4. The defect affects a critical airway-support device, and a torn securement flange poses significant risk to patient safety, despite no illnesses being reported in the source.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of Bivona Tracheostomy Silicone Tubes for pediatric and adult patients. The affected products are identified by codes 65P025 through 65P055, representing tube sizes from 2.5mm to 5.5mm diameter, with specific lot numbers for each size. The distribution was worldwide.
The recall was initiated because the manufacturer identified a manufacturing defect in the securement flange of specific lots. The flange may tear due to this defect, which could affect device security and function.
Patients and healthcare facilities with affected tube lots should contact Smiths Medical ASD Inc. for further information and guidance on management of affected devices.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF…
- 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 15021312005943
- Product Code/List Number/Item Code 65P025
- Lot Codes: 3897888
- 3981971
- 4016049
- 4334862
- 4374393
- 4380064
- 4393387
- 4400619
- b) UDI/DI 15021312005950
- Product Code/List Number/Item Code 65P030
- Lot Codes: 3880701
- 3904666
- 3923718
- 3926981
- 3930042
- 4171565
- 4196257
- 4221324
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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