Recall Z-0928-2024— AtriCure, Inc.
Class II · Ongoing
Class II FDA medical device recall by AtriCure, Inc., initiated 2023-11-28. It names one FDA 510(k) clearance: K140058. Product: Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056. Reason: AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material..
- Recalling firm
- AtriCure, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-28
- Firm location
- Mason, OH, 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
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Reason for recall
AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
Data sourced from openFDA. This site is unofficial and independent of the FDA.