Smiths Medical Recalls Mislabelled Pediatric Tracheostomy Tubes
Smiths Medical is recalling 142 Bivona TTS Pediatric Tracheostomy Tubes because they were incorrectly labeled for neonatal use instead of pediatric use.
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 could cause temporary or medically reversible health consequences. The hazard is a labeling error (mis-labeling) rather than a structural defect or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
Smiths Medical ASD Inc. is recalling 142 units of the Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035. The recall was initiated because one lot of the 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for "neonatal" use rather than the correct "pediatric" designation.
The affected devices were distributed to facilities in California, Illinois, North Carolina, Georgia, Nebraska, Massachusetts, Colorado, Connecticut, Missouri, Tennessee, Louisiana, Maryland, Minnesota, Florida, South Carolina, Oklahoma, Michigan, Pennsylvania, Texas, Washington, and Wisconsin. The source text does not specify the exact dates of distribution or the specific facilities involved.
Consumers and healthcare providers should stop using the affected tracheostomy tubes and contact Smiths Medical ASD Inc. for further instructions or a replacement. The recall is limited to the specific model and lot identified in the agency's notice.
The recalled product
- Product
- Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 142
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)
- 3272963
Distribution
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