Recall Z-0654-2019— Bracco Injeneering S.A.
Class II · Terminated
Class II FDA medical device recall by Bracco Injeneering S.A., initiated 2018-11-12, terminated 2020-04-15. It names one FDA 510(k) clearance: K933846. 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.. Reason: Insufficient seal on the sterile barrier of the device, compromising the sterility of the device.
- Recalling firm
- Bracco Injeneering S.A.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-12
- Terminated
- 2020-04-15
- Firm location
- Lausanne, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
Data sourced from openFDA. This site is unofficial and independent of the FDA.