Date Initiated by Firm |
January 12, 2005 |
Date Posted |
April 06, 2005 |
Recall Status1 |
Terminated 3 on April 12, 2005 |
Recall Number |
Z-0669-05 |
Recall Event ID |
30971 |
Product Classification |
Heart-Valve, Allograft - Product Code MIE
|
Product |
CryoValve, Pulmonary Valve and Conduit |
Code Information |
Donor Number: 70022, Serial Number: 8056613, Model Number: 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 |
During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.
|
FDA Determined Cause 2 |
Other |
Action |
Consignee was notified by letter on 01/12/2005. |
Quantity in Commerce |
1 tissue |
Distribution |
KS |
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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