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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 CryoValve see related information
Date Initiated by Firm April 17, 2007
Date Posted June 07, 2007
Recall Status1 Terminated 3 on December 31, 2007
Recall Number Z-0841-2007
Recall Event ID 37876
Product Classification Pulmonary Valve & Conduit - Product Code MIE
Product CryoValve, Pulmonary Valve & Conduit
Code Information Donor number 87980, Serial number 8897314, Model Number PV00
Recalling Firm/
Manufacturer		 CryoLife, Inc.
1655 Roberts Blvd. NW
Kennesaw GA 30144-3632
For Additional Information Contact Bryan Brosseau
770-419-3355
Manufacturer Reason
for Recall		 Donor tissue was released prior to information received regarding a pericardial effusion.
FDA Determined
Cause 2		 Other
Action Both physicians were contacted by telephone on 4/17 & 18/2007. Both tissues were returned to CryoLife
Quantity in Commerce 1 tissue
Distribution AZ, CO
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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