AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
Check against the official notice below — it lists the full affected range.
The AXIUS Blower Mister (product code CB-1000), manufactured by Maquet Cardiovascular, LLC, has been recalled due to a potential lack of carbon dioxide (CO2) flow that may result in procedural delays during off-pump coronary artery bypass surgery. The device is designed to clear the surgical site for improved visibility during these procedures. A total of 7,880 units (1,576 packs of 5) have been distributed worldwide, including throughout the United States and in Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and the United Kingdom. The affected lot numbers are 96255605, 96255607, 96255608, 96255609, and 96255611.
The recall record does not specify a remedy or recommended course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
Reason for recall: Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB). Distribution: Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom. Quantity: 7,880 each (1,576 packs of 5) Lot/code info: Lot Numbers: 96255605,96255607,96255608,96255609,96255611 UDI: 20607567700745
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.