Cryolife Inc CryoValve, Pulmonary Valve and Conduit - SG Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve, Pulmonary Valve and Conduit - SG
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donor #55634, Serial #7250375, Model #SGPV00* Donor #60740, Serial #7756769, Model #SGPV00* Donor #60758, Serial #7765469, Model #SGPV00* Donor #60760, Serial #7753955, Model #SGPV00* Donor #63969, Serial #7907208, Model #SGPV00* Donor #64863, Serial #7865589, Model #SGPV00
Products Sold
Donor #55634, Serial #7250375, Model #SGPV00* Donor #60740, Serial #7756769, Model #SGPV00* Donor #60758, Serial #7765469, Model #SGPV00* Donor #60760, Serial #7753955, Model #SGPV00* Donor #63969, Serial #7907208, Model #SGPV00* Donor #64863, Serial #7865589, Model #SGPV00
Cryolife Inc is recalling CryoValve, Pulmonary Valve and Conduit - SG due to CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.
Recommended Action
Per FDA guidance
Consignees were notified by letter on/about May 6, 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 noticePage updated: Jan 10, 2026