FDA-Device2018-12-26Class II
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.
Bracco Injeneering S.A.
Hazard
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
Sold states
US Nationwide Distribution
Affected count
33,350 packs (667 cases)
Manufactured in
Avenue De Sevelin 46, Lausanne, Switzerland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0654-2019Don't want to check this manually?
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