Smiths Medical Recalls UniPerc Tracheostomy Tube Kits with Incorrect Obturator Size
Smiths Medical is recalling 89 UniPerc tracheostomy tube kits because they contain a 9.0mm obturator instead of the correct 8.0mm size.
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: This is a Class II recall involving a component size mismatch. No injuries or illnesses are reported in the source text, and the hazard is a functional defect rather than a direct toxic or biological threat, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smiths Medical ASD Inc. is recalling 89 units of the UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971. The recall is due to the presence of an incorrect 9.0mm sized obturator in the kits, whereas the correct size for this 8.0mm tube is 8.0mm.
The affected products are intended for use during the surgical placement of a stoma or as a replacement tube for patients with larger necks. The distribution was international only, covering the United Kingdom, France, Austria, Germany, Italy, Sweden, Ireland, Belgium, Spain, and Luxembourg.
Consumers and healthcare providers should stop using the affected kits and contact Smiths Medical for further instructions.
The recalled product
- Product
- UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy…
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 89
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 3308971
Distribution
Distribution scope not specified by the agency.
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