Device product
Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
Z-0577-2018
Product summary
- Event
- Event 79045
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-0577-2018
Official wording
Reason: Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Code information: GS025081
Distribution pattern: International Distribution to:Germany
Derived failure modes
-
Unknown
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.