Cryolife Inc CryoValve, Aortic Valve & Conduit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve, Aortic Valve & Conduit
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donor #69588, Serial #8069423, Model #AV00
Products Sold
Donor #69588, Serial #8069423, Model #AV00
Cryolife Inc is recalling CryoValve, Aortic Valve & Conduit due to Microorganisms were detected in donor tissue associated with this allograft, specifically Aeormonas hydrophila.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Microorganisms were detected in donor tissue associated with this allograft, specifically Aeormonas hydrophila.
Recommended Action
Per FDA guidance
Consignee was notified first by telephone on 02/20/2004, then with follow up letter on 04/02/2004.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN
Page updated: Jan 10, 2026