CryoValve SG Cryopreserved Pulmonary Human Heart Valve
FDA device recall Z-1545-2024 · posted 2024-04-16 · Open, Classified
Recall details
- Recalling firm
- Artivion, Inc
- Reason for recall
- The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
- Action taken
- The single consignee was notified via email on 03/06/2024 with an amended letter sent on 03/14/2024. The first letter indicated to quarantine and return the affected unit, if not implanted. The consignee was requested to complete and return the response form.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OHA
- Quantity affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of Ohio.
- Date initiated
- 2024-03-06
- Date posted
- 2024-04-16
- Location
- Kennesaw, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) (K092021) | Cryolife, Inc. | 2010-05-25 |