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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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.
FDA Enforcement
Class II
·Terminated·Bracco Injeneering S.A.·December 26, 2018
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.
FDA Recall
Terminated
·Bracco Injeneering S.A. Avenue De Sevelin 46 Lausanne Switzerland·Product code DXT·November 12, 2018