medical Class II Updated 2024-02-07

AtriCure, Inc. recalls Cryo Module Accessories Domestic CMA-OUS, Product Catalog

Recalled Product

Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 10840143903038; Lot Numbers: 129673, 129674, 129882, 130314, 130750, 131614, 132669, 133672, 133673, 134270
View official government recall

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