Shiley tracheostomy tubes recalled over incorrect display box labeling
Covidien Shiley Tracheostomy Tubes with inner cannula, REF 6FEN, are being recalled following a customer complaint about incorrect display box labeling. 1,002 units are affected.
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: FDA Class II recall for a labeling error on the outer display box with no product defect or hazard described in the source, which fits the Moderate band.
Plain-English summary
The COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula, REF 6FEN, UDI-DI 60884522007028, lot 25H0868JZX, is being recalled. The tubes provide tracheal access for airway management. The action covers 1,002 units.
The recall follows a customer complaint regarding incorrect display box labeling. The FDA classified the action as Class II. The source does not describe any defect in the tubes themselves or any resulting hazard.
Distribution was worldwide, including nationwide in the United States with units in Texas and in other countries. The tubes are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the product number, UDI-DI and lot number above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner…
- Manufacturer
- Covidien LLC
- Affected units
- 1,002
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)
- Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
Distribution
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