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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm November 19, 2003
Date Posted November 30, 2005
Recall Status1 Terminated 3 on July 02, 2009
Recall Number Z-0212-06
Recall Event ID 32850
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve, Alt Pulmonary Valve & Conduit
Code Information Donor #28776, Serial #6162886, Model #PV05, Donor #29275, Serial #6180566, Model #PV05, Donor #30815, Serial #6235387, Model #PV05 
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information Contact Mr. 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
Action Consignees were notified by letter starting 11/17/2003.
Quantity in Commerce 3 units
Distribution AR, AZ, CA, CT, DC, FL, IL, LA, MN, NC, NH, NV, NY, TN, TX, UT, and Germany.
Total Product Life Cycle TPLC 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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