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

FDA Recall #Z-0927-2024 — Class II — November 28, 2023

Recall #Z-0927-2024 Date: November 28, 2023 Classification: Class II Status: Ongoing

Product Description

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

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 does not have required pin perforations and the inner tube of the hose is not the correct material.

Recalling Firm

AtriCure, Inc. — Mason, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

35

Distribution

US Nationwide. Brazil, Canada, Japan, Taiwan

Code Information

UDI-DI: 10840143903038; Lot Numbers: 129673, 129674, 129882, 130314, 130750, 131614, 132669, 133672, 133673, 134270

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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