Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Packaging Error
Smiths Medical is recalling 238 Bivona Cuffless FlexTend Tracheostomy Tubes because they may have been incorrectly packaged with a V-neck flange instead of a straight flange.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a packaging error (wrong flange) rather than a direct contamination or structural defect causing immediate harm, fitting the criteria for moderate severity.
Plain-English summary
Smiths Medical ASD Inc. is recalling 238 units of the PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45. The recall involves devices from Lot Number 3991195 that were distributed nationwide in the United States.
The recall was initiated because the specific model and lot number may have been incorrectly packaged with a V-neck flange instead of the intended straight flange. This packaging error could result in the wrong component being used for the device.
Healthcare providers and consumers should check their inventory for this specific product and lot number. If the product is found, it should be stopped from use and returned to Smiths Medical ASD Inc. for further instructions.
The recalled product
- Product
- PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 238
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 (1)
- Lot Number 3991195
Distribution
Distributed nationwide across the United States.
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