On-X Aortic Heart Valve with Anatomic Sewing Ring recall: Labeling Error
On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased…
Why was On-X Aortic Heart Valve with Anatomic Sewing Ring recalled?
On-X Valve was mislabeled with the incorrect serial number.
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?
Model/Catalog Number ONXANE - 23, Lot number 6827216, Expiration Date 11/19/2024
- Product
- On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased…
- Recalling firm
- CryoLife, Inc.
- Quantity
- 2 devices
- Distribution
- Worldwide Distribution - US Nationwide - Georgia and Germany.
- Recall date
- April 3, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)