Maquet Cardiovascular, LLC recalls AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site f…

Recall date

January 24, 2019

Source

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

Recall number

Z-0983-2019

FDA classification

Class II

Brand / firm

Maquet Cardiovascular, LLC

Sold / distributed

Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom.

Why it was recalled

Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).

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

What was recalled

AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility