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U.S. Department of Health and Human Services

Class 2 Device Recall CryoValve Allograft heart valve

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  Class 2 Device Recall CryoValve Allograft heart valve see related information
Date Initiated by Firm January 23, 2003
Date Posted March 21, 2003
Recall Status1 Terminated 3 on March 22, 2004
Recall Number Z-0675-03
Recall Event ID 25593
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve Allograft heart valve
Code Information Model number SGPV00, Serial Number: 7291867, Donor #55899
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144
For Additional Information Contact Sheri Allen
678-290-4313
Manufacturer Reason
for Recall		 An allograft associated with this donor has been linked to an alleged infection.
FDA Determined
Cause 2		 Other
Action A CryoLife Technical Representative notified the consignee by telephone on/about 1/23/2003 to determine the disposition of the allograft. Allograft SID 7291867 (SGPV00) was located in storage at the St. Vincent''s Hospital, Indianapolis, IN. A CryoLife representative visited this site on 01/30/2003 to remove the allograft from inventory and return the tissue to CryoLife. After arrival at CryoLife on 02/03/2003, discard of the tissue was initiated following standard procedures for human tissue waste destruction
Quantity in Commerce 1 unit
Distribution The unit was distributed to one Hospital facility in IN. There are no foreign or government 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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