Device product
Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
Z-1078-2015
Product summary
- Firm
- Teleflex Medical
- Event
- Event 70248
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 units
- Official record key
device-enforcement:Z-1078-2015
Official wording
Reason: Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.
Code information: Catalog no. 5-22110, Lot no. 01M1300076.
Distribution pattern: Worldwide Distribution - US Distribution to the states of FL, GA, IL, KY, MA, MI, MO, MS, OH, TX, WA and WV., and to the countries of Canada and the Netherlands.
Derived failure modes
-
Labeling or packaging
incorrectly labeled