Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
This recall is currently active, issued January 31, 2024. It was issued by Atricure, Inc..
- Company
- Atricure, Inc.
- Recall Initiated
- November 28, 2023
- Posted
- January 31, 2024
- Recall Number
- Z-0927-2024
- Quantity
- 35
- Firm Location
- Mason, OH
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide. Brazil, Canada, Japan, Taiwan
Lot / Code Info
UDI-DI: 10840143903038; Lot Numbers: 129673, 129674, 129882, 130314, 130750, 131614, 132669, 133672, 133673, 134270
Root Cause
Other
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.