COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI cod...
Reason for Recall / Hazard
Due to customer complaint regarding incorrect display box labeling.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Boulder |
| State | CO |
| Event id | 98813 |
| Address 1 | 6135 Gunbarrel Ave |
| Code info | Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX |
| Postal code | 80301-3214 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 1,002 |
| Reason for recall | Due to customer complaint regarding incorrect display box labeling. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260415 |
| Initial firm notification | Letter |
| Center classification date | 20260529 |
Overview
- Recalling FirmCovidien LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.