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U.S. Department of Health and Human Services

Class 2 Device Recall CryoValve

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 Class 2 Device Recall CryoValvesee related information
Date Initiated by FirmNovember 10, 2003
Date PostedFebruary 10, 2004
Recall Status1 Terminated 3 on May 06, 2004
Recall NumberZ-0516-04
Recall Event ID 27949
Product Classification Heart-Valve, Allograft - Product Code MIE
ProductCryoValve, Pulmonary Valve & Conduit
Code Information Donor number: 71237, Serial number: 8214013, Model number: PV00
FEI Number 3001451326
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information ContactP. Tyler Cochran, CQA, CTBS
770-419-3355
Manufacturer Reason
for Recall		The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis.
FDA Determined
Cause 2		Other
ActionConsignee 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.
Quantity in Commerce1 unit
DistributionThe tissue was issued to one hospital in CA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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