Drug recall
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
FDA recall event 93672 · Class II · AtriCure, Inc.
Key facts
| Event ID | 93672 |
|---|---|
| Recall numbers | Z-0927-2024, Z-0928-2024 |
| Recalling firm | AtriCure, Inc. |
| Product type | Devices |
| Products | Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053, Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 28, 2023 |
| Report date | Feb 7, 2024 |
| City | Mason |
| State | OH |
| Country | United States |
| FEI number | 3011706110 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: