FDAJanuary 24, 2019device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

maquet cardiovascularmaquet

UPCs

20607567700745

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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