Artivion, Inc recalls CryoValve SG Cryopreserved Pulmonary Human Heart Valve
- Recall date
- March 6, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1545-2024
- FDA classification
- Class II
- Brand / firm
- Artivion, Inc
- Sold / distributed
- US Nationwide distribution in the state of Ohio.
Why it was recalled
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
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