FDA recall Z-0983-2019

Product

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

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.

Key facts

Status

Terminated

Initiation date

2019-01-24

Report date

2019-03-13

Termination date

2020-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0983-2019