Recall Z-0654-2019
Bracco Injeneering S.A. · initiated November 12, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot # IANBL-1804 UDI: (01) 17630039300309 (17) 210420 (11) 180420 (10) IANBL-1804
Reason for recall
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-0654-2019
- Initiated
- November 12, 2018
- Terminated
- April 15, 2020
- Product code
- DXT – Injector And Syringe, Angiographic
- Quantity
- 33,350 packs (667 cases)
- Distribution
- US Nationwide Distribution
- Recalling firm
- Bracco Injeneering S.A., Lausanne