CryoValve SG Cryopreserved Pulmonary Human Heart Valve
This recall is currently active, issued April 16, 2024. It was issued by Artivion, Inc.
- Company
- Artivion, Inc
- Recall Initiated
- March 6, 2024
- Posted
- April 16, 2024
- Recall Number
- Z-1545-2024
- Quantity
- 1 unit
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
Reason for Recall
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Distribution
US Nationwide distribution in the state of Ohio.
Lot / Code Info
Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028
Root Cause
Under Investigation by firm
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.