Covidien Shiley Disposable Decannulation Plug product labeling error
Covidien LLC is recalling Shiley Disposable Decannulation Plug devices because the product labeling incorrectly indicates the product does not contain DEHP, when in fact the product contains 30 to 35% DEHP.
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 an FDA Class II recall involving a labeling error where the product's actual composition (DEHP content) differs from what the labeling states. No reported illnesses or injuries are mentioned in the source text, and the hazard is informational rather than acute.
Plain-English summary
Covidien LLC is recalling Covidien Shiley Disposable Decannulation Plug devices (REF DDCP) due to a labeling error. The product labeling incorrectly includes a symbol indicating the product does not contain DEHP (Bis(2-ethylhexyl) phthalate), when the product actually contains 30 to 35% DEHP.
The Shiley Disposable Decannulation Plug is a universal size connector used to occlude the proximal end of the outer cannula on Shiley Tracheostomy Tubes. The device blocks airflow through the tube and directs breathing through the mouth and nose, and is intended for use in providing tracheal access for airway management.
Approximately 293,659 devices have been distributed nationwide throughout the United States and its territories, as well as internationally to multiple countries. Consumers and healthcare providers who have these devices should be aware of the labeling discrepancy and the actual DEHP content.
The recalled product
- Product
- Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN…
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 293,659
Distribution
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