Device recall
Z-0654-2019: Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with…
FDA device recall · Class II · Bracco Injeneering S.A.
Key facts
| Recall number (Z-number) | Z-0654-2019 |
|---|---|
| Recall event | 81616 |
| 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… |
| Product code | DXT |
| Recalling firm | Bracco Injeneering S.A. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 15, 2020 |
| 510(k) numbers | K933846 |
| FEI number | 3004753774 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database