Smiths Medical Recalls Pediatric Tracheostomy Tubes Due to Packaging Error
Smiths Medical is recalling 20 pediatric tracheostomy tubes because one lot was packaged with the wrong size flange plate.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The issue is a packaging error involving the wrong size flange plate, which is a labeling/packaging defect rather than a direct contamination or structural failure leading to immediate severe injury.
Plain-English summary
Smiths Medical ASD Inc. is recalling 20 units of Pediatric Adjustable Flange Tracheostomy Tube Cuffless, Model 60HA30, Lot 3794165. The recall was initiated because one lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
The affected devices were distributed in the United States to Nebraska, Tennessee, Texas, and Mississippi, as well as internationally to France, Sweden, the United Arab Emirates, the United Kingdom, the Netherlands, Czechia, Australia, and Denmark.
Healthcare providers and consumers should stop using the affected devices and contact Smiths Medical for instructions on return or replacement.
The recalled product
- Product
- Pediatric Adjustable Flange Tracheostomy Tube Cuffless
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 20
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)
- Model Number: 60HA30
- Lot: 3794165
- SKU 60HA30
Distribution
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