Z-0654-2019 Class II Terminated
FDA device recall Z-0654-2019 was initiated by Bracco Injeneering S.A. on November 12, 2018 and is designated Class II. Reason for recall: Insufficient seal on the sterile barrier of the device, compromising the sterility of the device The recall status is terminated (terminated April 15, 2020). Affected quantity: 33,350 packs (667 cases).
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2018
- Initiation Date
- November 12, 2018
- Termination Date
- April 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,350 packs (667 cases)
Product 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.
Reason for Recall
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device
Distribution Pattern
US Nationwide Distribution
Code Information
Lot # IANBL-1804 UDI: (01) 17630039300309 (17) 210420 (11) 180420 (10) IANBL-1804