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Bracco Injeneering S.A. recalls Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA
Recalled December 26, 2018 · FDA recall Z-0654-2019 · Bracco Injeneering S.A
Hazard
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device · FDA Class II
Units
33,350 packs (667 cases)
Sold at
US Nationwide Distribution
Description
Insufficient seal on the sterile barrier of the device, compromising the sterility of the 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.
Manufacturer(s)
Bracco Injeneering S.A.
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →