Z-0983-2019 Class II Terminated
FDA device recall Z-0983-2019 was initiated by Maquet Cardiovascular, LLC on January 24, 2019 and is designated Class II. Reason for recall: Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB). The recall status is terminated (terminated July 13, 2020). Affected quantity: 7,880 each (1,576 packs of 5).
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2019
- Initiation Date
- January 24, 2019
- Termination Date
- July 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,880 each (1,576 packs of 5)
Product Description
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 Pattern
Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom.
Code Information
Lot Numbers: 96255605,96255607,96255608,96255609,96255611 UDI: 20607567700745