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 #68206, Serial #7960244, Model #PV00, Donor #68241, Serial #7971710, Model #PV00, Donor #68422, Serial #8047344, Model #PV00, Donor #69368, Serial #8022398, Model #PV00, Donor #69826, Serial #8071361, Model #PV00, Donor #69934, Serial #8059703, Model #PV00, Donor #67086, Serial #7993957, Model #PV00, Donor #30309, Serial #6218156, Model #PV00
Products Sold
Donor #68206, Serial #7960244, Model #PV00, Donor #68241, Serial #7971710, Model #PV00, Donor #68422, Serial #8047344, Model #PV00, Donor #69368, Serial #8022398, Model #PV00, Donor #69826, Serial #8071361, Model #PV00, Donor #69934, Serial #8059703, Model #PV00, Donor #67086, Serial #7993957, Model #PV00, Donor #30309, Serial #6218156, Model #PV00
Cryolife Inc is recalling CryoValve, Pulmonary Valve & Conduit due to Previously released tissues no longer meet CryoLife's enhanced suitability release criteria because donors possessed a positive post processing microb. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Previously released tissues no longer meet CryoLife's enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of 'potentially pathogenic' organisms.
Recommended Action
Per FDA guidance
Consignees were notified by letter starting 11/17/2003.
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
AZ, AR, CA, CT, FL, IL, LA, MN, NV, NH, NY, NC, TN, TX, UT, DC
Page updated: Jan 10, 2026