Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for… — Class II medical device recall Z-0654-2019
Terminated recall by Bracco Injeneering S.A., reported 2018-12-26, distributed nationwide. Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
| Recall number | Z-0654-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bracco Injeneering S.A., Lausanne, Switzerland |
| Recall initiated | 2018-11-12 |
| Classified | 2018-12-20 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-04-15 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 17630039300309 |
| Lot numbers | IANBL-1804 |
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 for recall
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0654-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.