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
- Recall Number
- Z-0654-2019
- Event Number
- 81616
- Firm
- Bracco Injeneering S.A. Avenue De Sevelin 46 Lausanne Switzerland
- FEI Number
- 3004753774
- Product Code
- DXT
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- November 12, 2018
- Terminated
- April 15, 2020
Description
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.
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
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 [email protected].
US Nationwide Distribution
33,350 packs (667 cases)