Cryolife Inc CryoValve, Pulmonary Valve and Conduit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve, Pulmonary Valve and Conduit
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donor #68538, Serial #8045214, Model #PV00
Products Sold
Donor #68538, Serial #8045214, Model #PV00
Cryolife Inc is recalling CryoValve, Pulmonary Valve and Conduit due to Mislabeling; An allograft labeled as an aortic valve & conduit, actually contained a pulmonary valve and conduit.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeling; An allograft labeled as an aortic valve & conduit, actually contained a pulmonary valve and conduit.
Recommended Action
Per FDA guidance
Consignee was notified by letter on 01/26/2004. The tissue was returned to CryoLife and destroyed.
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
Page updated: Jan 10, 2026