Bracco Injeneering S.A.: Medical Device Recall in 2018 - (Recall #: Z-0654-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 12, 2018

Date Posted: December 26, 2018

Recall Number: Z-0654-2019

Event ID: 81616

Reason for Recall:

Insufficient seal on the sterile barrier of the device, compromising the sterility of the device

Status: Terminated

Product Quantity: 33,350 packs (667 cases)

Code Information:

Lot # IANBL-1804 UDI: (01) 17630039300309 (17) 210420 (11) 180420 (10) IANBL-1804

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated