Recall Z-0654-2019 ยท DXT Injector And Syringe, Angiographic
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 solutio
| Date | Nov 12, 2018 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933846 | ANGIOGRAPHY SYRINGE KITS Angiodynamics, Div. E-Z-Em, Inc., Dec 13, 1994 |