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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 March 26, 2008
Date Posted September 01, 2008
Recall Status1 Terminated 3 on January 12, 2010
Recall Number Z-1523-2008
Recall Event ID 47517
510(K)Number K033484  
Product Classification Allograft heart valve - Product Code MIE
Product CryoValve, Aortic Valve & Conduit
Code Information Donor number 87732, Serial number 8895131
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		 Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
FDA Determined
Cause 2		 Material/Component Contamination
Action Hospitals were notified by letter on 3/24/2008. They were advised not to implanted the tissue and if implanted, they do not recommend explant unless medically necessary. A self addressed, stamped post card was included to confirm receipt of the notification. Serial number 8895391 was reported implanted. Serial number 8895131 was returned to CryoLife for destruction.
Quantity in Commerce 1 tissue
Distribution Hospitals in DE, TN
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.
510(K) Database 510(K)s with Product Code = MIE and Original Applicant = CRYOLIFE, INC.
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