Smiths Medical Recalls Portex Tracheostomy Tubes with Incorrect Inner Cannula Size
Smiths Medical ASD Inc. is recalling 7,840 Portex Blue Line Ultra Tracheostomy Tubes because they were packaged with an incorrect size inner cannula.
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 adverse health consequences. The hazard is a packaging error (incorrect size) rather than a contamination or structural failure, and no injuries are reported.
Plain-English summary
Smiths Medical ASD Inc. is recalling 7,840 units of the Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. The recall is due to a packaging error where the tubes were shipped with an incorrect size inner cannula. The affected product is identified by item code 100/856/080 and lot number 3578884.
The affected units were distributed worldwide, including in the United States (AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA), Canada, the UK, and Ireland. These devices are indicated for airway maintenance of tracheostomized patients.
Consumers and healthcare facilities should stop using the affected devices and contact Smiths Medical ASD Inc. for further instructions or a replacement.
The recalled product
- Product
- Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 7,840
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)
- Item code/product number: 100/856/080 lot number: 3578884
Distribution
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