FDA Enforcement
Class II
Terminated
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.
Recall: Z-0654-2019
·
Reported December 26, 2018
Enforcement
- Recall Number
- Z-0654-2019
- Event ID
- 81616
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Bracco Injeneering S.A.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 26, 2018
- Initiation Date
- November 12, 2018
- Classification Date
- December 20, 2018
- Termination Date
- April 15, 2020
- Address
- Avenue De Sevelin 46, Lausanne, N/A, Switzerland
Description
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.
Reason
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
Code Info
Lot # IANBL-1804 UDI: (01) 17630039300309 (17) 210420 (11) 180420 (10) IANBL-1804
Distribution
US Nationwide Distribution
Quantity
33,350 packs (667 cases)