Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for Recalled by Bracco Injeneering S.A. Due to Insufficient seal on the sterile barrier of the...

Date: November 12, 2018
Company: Bracco Injeneering S.A.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bracco Injeneering S.A. directly.

Affected Products

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.

Quantity: 33,350 packs (667 cases)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bracco Injeneering S.A.

Bracco Injeneering S.A. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report