Cryolife Inc CryoValve, Pulmonary Valve & Conduit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve, Pulmonary Valve & Conduit
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donor number 78142, Serial number 8306247, Model number PV00
Products Sold
Donor number 78142, Serial number 8306247, Model number PV00
Cryolife Inc is recalling CryoValve, Pulmonary Valve & Conduit due to Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.
Recommended Action
Per FDA guidance
Physicians were notified by letter on 1/27/2006.
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
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Page updated: Jan 10, 2026