Device product
SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.
Z-0619-2019
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 81615
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31,050 units
- Official record key
device-enforcement:Z-0619-2019
Official wording
Reason: There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
Code information: UDI 108877870074, All codes
Distribution pattern: US distribution and Internationally to Canada.
Derived failure modes
-
Unknown
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.