Cryolife Inc Pulmonary Valve & Conduit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pulmonary Valve & Conduit
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donor #77647, Serial #8471383, Model #PV00
Products Sold
Donor #77647, Serial #8471383, Model #PV00
Cryolife Inc is recalling Pulmonary Valve & Conduit due to Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife'. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.
Recommended Action
Per FDA guidance
Consignees were notified by telephone on May 17, 2005. Both tissues were returned 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
IL, MT
Page updated: Jan 10, 2026