Shiley Adult Tracheostomy Tubes Recalled Due to Flange Disconnection Risk
Covidien is recalling 780 Shiley Adult Flexible Tracheostomy Tubes because the flange may disconnect from the outer cannula, potentially causing respiratory failure, aspiration, or death.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is classified as FDA Class I, which mandates a minimum severity of Severe. The defect poses serious risk of respiratory failure or death, though no reported illnesses or injuries have been documented.
Plain-English summary
Covidien is recalling Shiley Adult Flexible Tracheostomy Tubes with TaperGuard Cuff Reusable Inner Cannula (Model REF: 7CN80R, Lot 202405258X, expiration June 1, 2029). The recall affects 780 units distributed exclusively outside the United States.
The tracheostomy tube's flange may disconnect from the outer cannula, creating a potentially dangerous gap in the airway device. This defect could lead to respiratory failure, aspiration, tissue injury, respiratory tract infection, bronchospasm, or a critical delay in treatment.
The recalled tubes were distributed to 12 countries: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, and Taiwan. Patients currently using these devices should contact their healthcare provider or Covidien immediately for guidance on safe replacement.
The recalled product
- Product
- Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
- Manufacturer
- Covidien
- Category
- Medical Device — Respiratory
- Hazard
- Affected units
- 780
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 (3)
- UDI-DI/GTIN: A8845212054401
- 20884521205441
- 10884521205444. Lot: 202405258X. Expiration: 06/01/2029
Distribution
Distribution scope not specified by the agency.
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