EPi-Sense Guided Coagulation System with Visitrax recall
EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists…
Why was EPi-Sense Guided Coagulation System with Visitrax recalled?
The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has a worst-case reasonable harm of infection if used.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lots 70638, 71332, 89208, 89938, 90624
- Product
- EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists…
- Recalling firm
- AtriCure, Inc.
- Quantity
- 497
- Distribution
- Worldwide distribution - US Nationwide distribution, and countries of Germany and Netherlands.
- Recall date
- July 3, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)