Recall Z-0983-2019— Maquet Cardiovascular, LLC
Class II · Terminated
Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2019-01-24, terminated 2020-07-13. It names one FDA 510(k) clearance: K983135. 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: Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB)..
- Recalling firm
- Maquet Cardiovascular, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-01-24
- Terminated
- 2020-07-13
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.