Device 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.
Z-2261-2026
Product summary
- Firm
- Covidien LLC
- Event
- Event 98813
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,002
- Official record key
device-enforcement:Z-2261-2026
Official wording
Reason: Due to customer complaint regarding incorrect display box labeling.
Code information: Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
Distribution pattern: Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
Derived failure modes
-
Unknown
Due to customer complaint regarding incorrect display box labeling.