CryoValve SG Cryopreserved Pulmonary Human Heart Valve
FDA Recall #Z-1545-2024 — Class II — March 6, 2024
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.
Recalling Firm
Artivion, Inc — Kennesaw, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1 unit
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated