Cryo Module Accessories Domestic CMA-OUS recall
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Why was Cryo Module Accessories Domestic CMA-OUS 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 10840143903038; Lot Numbers: 129673, 129674, 129882, 130314, 130750, 131614, 132669, 133672, 133673, 134270
- Product
- Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
- Recalling firm
- AtriCure, Inc.
- Quantity
- 35
- Distribution
- US Nationwide. Brazil, Canada, Japan, Taiwan
- Recall date
- February 7, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)