Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Reported: February 7, 2024 Initiated: November 28, 2023 #Z-0927-2024
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.
Details
- Recalling Firm
- AtriCure, Inc.
- Units Affected
- 35
- Distribution
- US Nationwide. Brazil, Canada, Japan, Taiwan
- Location
- Mason, OH
Frequently Asked Questions
What product was recalled? ▼
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053. Recalled by AtriCure, Inc.. Units affected: 35.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 7, 2024. Severity: Moderate. Recall number: Z-0927-2024.
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