CryoValve SG Cryopreserved Pulmonary Human Heart Valve recall
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Why was CryoValve SG Cryopreserved Pulmonary Human Heart Valve recalled?
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028
- Product
- CryoValve SG Cryopreserved Pulmonary Human Heart Valve
- Recalling firm
- Artivion, Inc
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of Ohio.
- Recall date
- April 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)