Device product
Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems SKU 017344/6720 Empower FastLoad" CT Syringe Pack is a sterile, disposable syringe kit designed for use with EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems. It is used to intravenously facilitate the administration of contrast media and flushing solutions into the human vascular systems.
Z-0654-2019
Product summary
- Event
- Event 81616
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33,350 packs (667 cases)
- Official record key
device-enforcement:Z-0654-2019
Official wording
Reason: Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
Code information: Lot # IANBL-1804 UDI: (01) 17630039300309 (17) 210420 (11) 180420 (10) IANBL-1804
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device