Medrad Inc dba Bayer R&I recalls MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intraveno…

Recall date

September 20, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1686-2015

FDA classification

Class II

Brand / firm

Medrad Inc dba Bayer R&I

Sold / distributed

Nationwide Distribution

Why it was recalled

The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.