Bracco Injeneering S.A. recalls Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCT…
- Recall date
- November 12, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0654-2019
- FDA classification
- Class II
- Brand / firm
- Bracco Injeneering S.A.
- Sold / distributed
- US Nationwide Distribution
Why it was recalled
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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