Reported Feb 7, 2024 · Ongoing
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
AtriCure, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AtriCure, Inc. · 7555 Innovation Way · Mason, OH · 45040-9695
Is this the product you have?
- Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
- Lot codes and dates
- UDI-DI10840143903038
- Lot Numbers
129673129674129882130314130750131614132669133672133673134270
- Amount recalled
- 35
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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