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U.S. Department of Health and Human Services

Class 2 Device Recall CryoValve, Allograft

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  Class 2 Device Recall CryoValve, Allograft see related information
Date Initiated by Firm February 04, 2003
Date Posted August 28, 2003
Recall Status1 Terminated 3 on August 28, 2003
Recall Number Z-1187-03
Recall Event ID 25772
Product Classification Heart-Valve, Allograft - Product Code MIE
Product Heart-valve, allograft
Code Information Donor #60741, Model #SGAV10, Serial #783013
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144
For Additional Information Contact Shari L. Allen
770-419-3355
Manufacturer Reason
for Recall		 Donor of aortic valve had procurement cultures that were positive for E-coli.
FDA Determined
Cause 2		 Other
Action A CryoLife representative contacted the consignee by telephone on 2/4/2002 to inform her of the recall action. The graft was returned to CryoLife and destroyed on/about 2/11/2003.
Quantity in Commerce 1 unit
Distribution Allograft was distrbuted to one medical facility in CA. No government or foreign accounts involved.
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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