Aortic Arch Cannula and Coronary Artery Perfusion recall
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the…
Why was Aortic Arch Cannula and Coronary Artery Perfusion recalled?
Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.
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?
Lot Numbers: 1526500032, 1529300026, 1602600042.
- Product
- Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the…
- Recalling firm
- Sorin Group USA, Inc.
- Quantity
- 200 units worldwide
- Distribution
- Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.
- Recall date
- September 14, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)