FDA Medical Device Recalls (openFDA)
Bracco Injeneering S.A.: 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.
- Recall number
- Z-0654-2019
- Recalling firm
- Bracco Injeneering S.A.
- 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.
- Status
- Terminated
- Initiated
- 2018-11-12
- Posted
- not on file
- Terminated
- 2020-04-15
- Reason
- Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
- Root cause
- Packaging process control
- Action
- The firm, Bracco Injeneering, issued "URGENT: MEDICAL DEVICE RECALL" letter via third party recall firm, on 11/12/18 to customers and distributors identifying the problem, and requesting return of unused product., Complete and return the Removal Recall Response Form even if you have no recalled stock on hand. Questions: contact Stericycle at 888-759-6907 (Monday- Friday 8 a.m. to 5 p.m. Eastern Time) or acistmedical3021@stericycle.com.
- Quantity
- 33,350 packs (667 cases)
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot # IANBL-1804 UDI: (01) 17630039300309 (17) 210420 (11) 180420 (10) IANBL-1804
- 510(k) numbers
- ["K933846"]
- PMA numbers
- not on file
- Product code
- DXT
- Firm FEI
- 3004753774
- Firm city
- Lausanne
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28