Class II
Medical Device Recall: CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Artivion, Inc · March 6, 2024
Reason for Recall
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Distribution
US Nationwide distribution in the state of Ohio.
States Affected
NATIONWIDE
Quantity Affected
1 unit
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1545-2024
Status: ongoing
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