Covidien LLC: COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in pro
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Covidien LLC
- 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 cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.
- Reason / hazard
- Due to customer complaint regarding incorrect display box labeling.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
- Recall initiated
- 2026-04-15
- Code info
- Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
- Product quantity
- 1,002
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Boulder
- State
- CO
- Country
- United States
- Event id
- 98813
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