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: 71237, Serial number: 8214013, Model number: PV00
Products Sold
Donor number: 71237, Serial number: 8214013, Model number: PV00
Cryolife Inc is recalling CryoValve, Pulmonary Valve & Conduit due to The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures fo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis.
Recommended Action
Per FDA guidance
Consignee was first notified by telephone on 11/10/2003, with a follow up letter sent 12/10/2003. If the tissue had been implanted the consignee was advised to forward that information to CryoLife''s Regulatory Department-Field Assurance. If the tissue had not been implanted the consignee was advised not to implant or further distribute the tissue. They were instructed to remove the tissue from the implantable inventory and to place it into quarantine pending return to CryoLife. A self addressed, stamped postcard was included to affirm receipt of notification and to acknowledge that the tissue had been placed into quarantine.
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
CA, IN
Page updated: Jan 10, 2026