AtriCure, Inc. Recall 93672
Description: Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
AtriCure, Inc. Recall 93672 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0927-2024 |
| Event ID | 93672 |
| Event Description | Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 |
| Product Type | Devices |
| Distribution | US Nationwide. Brazil, Canada, Japan, Taiwan |
| Quantity | 35 |
| Recall 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. |
| Device Classification | 20240207 |
| Device Code Info | UDI-DI: 10840143903038; Lot Numbers: 129673, 129674, 129882, 130314, 130750, 131614, 132669, 133672, 133673, 134270 |
| Center Classification Date | 20240131 |
| Recall Initiation Date | 20231128 |
| Recalling Firm | AtriCure, Inc. |
| Initial Notification | Letter |
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