Date Initiated by Firm |
April 19, 2004 |
Date Posted |
September 28, 2005 |
Recall Status1 |
Terminated 3 on January 07, 2008 |
Recall Number |
Z-1591-05 |
Recall Event ID |
32841 |
Product Classification |
Heart-Valve, Allograft - Product Code MIE
|
Product |
CryoValve, Pulmonary Valve & Conduit SG |
Code Information |
Donor #62963, Serial #7819366, SGPPV00 |
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 |
This recall was initiated as part of the firm's retrospection review of tissues associated with complaints of alleged recipient infection.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by telephone and letter on 04/19/2004. |
Quantity in Commerce |
1 tissue |
Distribution |
MO, TX and Sidney Australia |
Total Product Life Cycle |
TPLC Device Report
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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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