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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 February 25, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on September 14, 2004
Recall Number Z-0855-04
Recall Event ID 28467
Product Classification Heart-Valve, Allograft - Product Code MIE
Product CryoValve Conduit and Pulmonary Valve and Conduit
Code Information Donor #71899, Serial #8080113, Model #PV00
Recalling Firm/
Manufacturer
Cryolife Inc
1655 Roberts Blvd Nw
Kennesaw GA 30144-3632
For Additional Information Contact Mr. P. Tyler Cochran, CQA, CTBS
770-419-3355
Manufacturer Reason
for Recall
A retrospective review of donor files conducted by CryoLife revealed an expired solution had been used during processing of the associated tissues.
FDA Determined
Cause 2
Other
Action Consignees were notified by letter on 03/02/2004.
Quantity in Commerce 1 unit
Distribution CA
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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