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 #68607, Serial #8044091, Model #PV00
Products Sold
Donor #68607, Serial #8044091, Model #PV00
Cryolife Inc is recalling CryoValve, Pulmonary Valve and Conduit due to CryoLife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to HCV (EIA) i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CryoLife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to HCV (EIA) in 1995.
Recommended Action
Per FDA guidance
Consignees were notified by telephone on 02/18/2004.
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
TX, DC
Page updated: Jan 10, 2026