FDA Device recall Z-0654-2019
Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems…
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems… by Bracco Injeneering, citing insufficient seal on the sterile barrier of the device, compromising the sterility of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0654-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-12 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bracco Injeneering |
| Distribution | US |
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
Identifiers
| code_info | Lot # IANBL-1804 UDI: (01) 17630039300309 (17) 210420 (11) 180420 (10) IANBL-1804 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0654-2019%22
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