FDA-Device2024-04-24Class II
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Artivion, Inc
Hazard
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Sold states
US Nationwide distribution in the state of Ohio.
Affected count
1 unit
Manufactured in
1655 Roberts Blvd Nw, Kennesaw, GA, United States
Products
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1545-2024Don't want to check this manually?
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