AXIUS Blower Mister recall
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
Why was AXIUS Blower Mister recalled?
Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 96255605,96255607,96255608,96255609,96255611 UDI: 20607567700745
- Product
- AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 7,880 each (1,576 packs of 5)
- Distribution
- Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom.
- Recall date
- March 13, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)