On-X Prosthetic Heart Valve with Gelweave Valsalva recall
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or…
Why was On-X Prosthetic Heart Valve with Gelweave Valsalva recalled?
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
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 No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902
- Product
- On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or…
- Recalling firm
- CryoLife, Inc.
- Quantity
- 5 units
- Distribution
- US Distribution to the state of : Illinois
- Recall date
- September 13, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)