Class II — Bracco Injeneering S.A.
| Recalling firm | Bracco Injeneering |
|---|---|
| Registered facility | Bracco Injeneering S.A. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Quantity | 33,350 packs (667 cases) |
| Distribution | US Nationwide Distribution |
| Initiated | 2018-11-12 |
| Classified | 2018-12-20 |
| Terminated | 2020-04-15 |
| Recall number | Z-0654-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bracco Injeneering S.A. (Z-0654-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81616/
Alerts for Bracco Injeneering
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.