Bayer Healthcare product recalled over fire hazard

Recall date

August 2, 2016

Source

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

Official notice title

Bayer Healthcare recalls Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial…

Recall number

Z-2768-2016

FDA classification

Class II

Brand / firm

Bayer Healthcare

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to United Arab Emirates, Australia, Canada, Germany, Spain, and United Kingdom.

Why it was recalled

CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire.

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

What was recalled

Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications