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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 FirmNovember 19, 2003
Date PostedNovember 30, 2005
Recall Status1 Terminated 3 on July 02, 2009
Recall NumberZ-0218-06
Recall Event ID 32850
Product Classification Heart-Valve, Allograft - Product Code MIE
ProductCryoValve, Pulmonary Valve & Conduit SG
Code Information Donor #65569, Serial #7949899, Model #SGPV00, Donor #66126, Serial #8111048, Model #SGPV00, Donor #67001, Serial #7996682, Model #SGPV00, Donor #67404, Serial #7972091, Model #SGPV00, Donor #61482, Serial #7692521, Model #SGPV00, Donor #66320, Serial #8099887, Model #SGPV00, Donor #66035, Serial #8103460, Model #SGPV00 
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		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.
FDA Determined
Cause 2		Other
ActionConsignees were notified by letter starting 11/17/2003.
Quantity in Commerce7 units
DistributionAR, AZ, CA, CT, DC, FL, IL, LA, MN, NC, NH, NV, NY, TN, TX, UT, and Germany.
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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