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

Recalled March 13, 2019 · FDA recall Z-0983-2019 · Maquet Cardiovascular

Hazard

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

Units

7,880 each (1,576 packs of 5)

Sold at

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

Description

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

Product

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

Manufacturer(s)

Maquet Cardiovascular, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →