Pediatric Tracheostomy Tube Recalled Due to Incorrect Box Expiration Date Label
Smiths Medical recalls a pediatric tracheostomy tube because the outer box shows an incorrect expiration date (3/17/2021) while the actual product has the correct date (3/17/2026). The discrepancy could cause confusion about product validity.
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: FDA Class II recall with a labeling discrepancy. No illnesses, injuries, or hospitalizations have been reported. The hazard is a packaging/labeling error rather than a physical product safety defect.
Plain-English summary
Smiths Medical ASD Inc. is recalling the Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045 (Lot #4125816) due to incorrect labeling on the outer unit box. The outer box displays an expiration date of 3/17/2021 (the manufacturing date), but the individual product packaging contains the correct expiration date of 3/17/2026.
The affected product was distributed to healthcare facilities in Arizona, California, Florida, Hawaii, Illinois, Indiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Ohio, Pennsylvania, South Carolina, Texas, Virginia, and Washington, as well as Canada.
The labeling discrepancy could cause confusion regarding the product's actual expiration date. Healthcare providers and end users should consult the expiration date on the individual product packaging to determine product validity.
The recalled product
- Product
- Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
- 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 (3)
- Lot #4125816
- exp. 3/17/2026
- UDI-DI 15021312005769.
Distribution
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