Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
FDA device recall Z-0928-2024 · posted 2024-01-31 · Open, Classified
Recall details
- Recalling firm
- AtriCure, Inc.
- 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.
- Action taken
- An URGENT: MEDICAL DEVICE RECALL notification letter dated 11/28/23 was sent to customers. Actions to be taken by the Customer/User: " If the Tank Hose assembly is part of the lots listed below, do not use the tank hose assembly. " If the lot number is listed below, work with your AtriCure sales rep to replace the device with a new Tank Hose assembly and return the recalled device. " Return the attached Medical Device Recall Return Response Acknowledgement and Receipt Form. Type of Action by the Company: AtriCure is arranging for the removal and replacement of the affected tank hose assemblies. If you have impacted product, AtriCure will provide a replacement product at no charge to you. If you have any questions, please contact Rob Cantu, Vice President of Quality at (1-513-755-4100) from 9-5pm ET on Mondays - Fridays. You may also contact customer service at (1-866-349-2342) any time of day, your message will be forwarded to Quality Assurance for prompt review.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- GEH
- Quantity affected
- 1
- Distribution
- US Nationwide. Brazil, Canada, Japan, Taiwan
- Date initiated
- 2023-11-28
- Date posted
- 2024-01-31
- Location
- Mason, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATRICURE CRYO MODULE SYSTEM (K140058) | AtriCure, Inc. | 2014-01-24 |