Bracco Injeneering S.A. recalls Empower FastLoad CT Syringe Pack -sterile disposable syringe
Recalled 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.
Hazard / Issue
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
Issued by
FDA
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