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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 06, 2004
Date PostedFebruary 04, 2006
Recall Status1 Terminated 3 on June 28, 2010
Recall NumberZ-0477-06
Recall Event ID 30233
Product Classification Heart-Valve, Allograft - Product Code MIE
ProductCryoValve, Pulmonary Valve & Conduit
Code Information Donor #40658, Serial #6547591, Model #PV00* Donor #40914, Serial #6565514, Model #PV00*  Donor #52097, Serial #7082478, Model #PV00*  Donor #52100, Serial #7085341, Model #PV00*  Donor #52647, Serial #7075544, Model #PV00*  Donor #54259, Serial #7284361, Model #PV00 
FEI Number 3001451326
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information ContactMr. P. Tyler Cochran, CQA, CTBS
770-419-3355
Manufacturer Reason
for Recall		During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter dated May 6, May 11, or May 12, 2004.
Quantity in Commerce6 units
DistributionFL, NC , NE, NV, NY, TN, TX, UT, WA, and Canada
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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