Teleflex Recalls Sheridan Cuffed Tracheal Tubes Due to Labeling Error
Teleflex Medical is recalling 14,000 Sheridan/CF Cuffed Tracheal Tubes because the label indicates size 8mm but the tube may be size 7.5mm.
What this means for you
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 and involves a minor labeling error regarding the size of the medical device, which fits the criteria for moderate severity.
Plain-English summary
Teleflex Medical is recalling 14,000 units of Sheridan/CF Cuffed Tracheal Tubes, sterile, prescription only. The product is designed for oral and nasal intubation and is indicated for airway management. The recall is due to a product labeling error where the units from the affected lot indicate that they contain a size 8mm tracheal tube, but they may actually contain a size 7.5mm tracheal tube.
The affected product is identified by Product Code 5-10116 and Lot number 01A1400211. The units were distributed worldwide, including in the U.S., Belgium, Canada, and Japan.
Healthcare providers and consumers should stop using the affected tracheal tubes and contact Teleflex Medical for further instructions or a replacement.
The recalled product
- Product
- Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 14,000
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)
- Product Code: 5-10116
- Lot number: 01A1400211
Distribution
Distribution scope not specified by the agency.
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