Z-1545-2024 Class II Ongoing
FDA device recall Z-1545-2024 was initiated by Artivion, Inc on March 6, 2024 and is designated Class II. Reason for recall: The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus. The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2024
- Initiation Date
- March 6, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Reason for Recall
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Distribution Pattern
US Nationwide distribution in the state of Ohio.
Code Information
Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028