FDA Enforcement
Class II
Ongoing
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Recall: Z-0927-2024
·
Reported February 7, 2024
Enforcement
- Recall Number
- Z-0927-2024
- 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
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
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: 10840143903038; Lot Numbers: 129673, 129674, 129882, 130314, 130750, 131614, 132669, 133672, 133673, 134270
Distribution
US Nationwide. Brazil, Canada, Japan, Taiwan
Quantity
35