Teleflex Recalls Preformed Tracheal Tubes Due to Incorrect Labeling
Teleflex Medical is recalling 300 units of preformed tracheal tubes because they are incorrectly labeled as cuffed oral tubes instead of uncuffed nasal tubes.
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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is limited to a labeling error, fitting the criteria for a moderate severity score.
Plain-English summary
Teleflex Medical is recalling 300 units of Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile. The recall is due to a labeling error where the affected product packaging is incorrectly identified as a cuffed oral ET tube, while the correct product labeling is an uncuffed nasal ET tube.
The affected units are identified by Catalog no. 5-22110 and Lot no. 01M1300076. These products were distributed worldwide, including to the United States states of FL, GA, IL, KY, MA, MI, MO, MS, OH, TX, WA, and WV, as well as to Canada and the Netherlands.
Healthcare providers and patients should stop using the affected units and contact Teleflex Medical for further instructions. The source text does not report any illnesses or injuries associated with this labeling error.
The recalled product
- Product
- Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 300
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 (2)
- Catalog no. 5-22110
- Lot no. 01M1300076.
Distribution
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Similar recalls
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