Device product
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Z-1545-2024
Product summary
- Firm
- Artivion, Inc
- Event
- Event 94250
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1545-2024
Official wording
Reason: The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Code information: Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028
Distribution pattern: US Nationwide distribution in the state of Ohio.
Derived failure modes
-
Unknown
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.