FDAFDA · Food and drugs·Recall number Z-1545-2024
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Published April 24, 2024 · Recall initiated: March 6, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Artivion, Inc
- Distributor
- US Nationwide distribution in the state of Ohio.
- Lot
- Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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