FDA Enforcement
Class II
Ongoing
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Recall: Z-0928-2024
·
Reported February 7, 2024
Enforcement
- Recall Number
- Z-0928-2024
- Event ID
- 93672
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- AtriCure, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 7, 2024
- Initiation Date
- November 28, 2023
- Classification Date
- January 31, 2024
- Address
- 7555 Innovation Way, Mason, OH, 45040-9695, United States
Description
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.
Code Info
UDI-DI: 10840143903076; Lot Number: 129675
Distribution
US Nationwide. Brazil, Canada, Japan, Taiwan
Quantity
1