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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 30, 2003
Date Posted March 21, 2003
Recall Status1 Terminated 3 on July 16, 2003
Recall Number Z-0676-03
Recall Event ID 25595
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve Allograft heart valve
Code Information Model number PV00, Serial Number: 7255205, Donor #56190
Recalling Firm/
Manufacturer		 Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144
For Additional Information Contact Connie J. Jones
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. The allograft SID 72552025 (V00) was located in storage at the SUNY University Hospital, Syracuse, NY. The 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 One unit was distributed to one Hospital facility in NY. 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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