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Artivion, Inc recalls CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Recalled April 24, 2024 · FDA recall Z-1545-2024 · Artivion
Hazard
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus. · FDA Class II
Units
1 unit
Sold at
US Nationwide distribution in the state of Ohio.
Description
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Product
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Manufacturer(s)
Artivion, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →