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Class 2 Device Recall |
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Date Initiated by Firm |
May 06, 2004 |
Date Posted |
November 03, 2004 |
Recall Status1 |
Terminated 3 on June 29, 2010 |
Recall Number |
Z-0172-05 |
Recall Event ID |
30218 |
Product Classification |
Heart-Valve, Allograft - Product Code MIE
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Product |
CryoValve, Aortic Valve & Conduit SG |
Code Information |
Donor #60727, Serial #7763406, Model #SGAV00* Donor #62532, Serial #7818159, Model #SGAV00* Donor #64863, Serial #7865603, Model #SGAV00* Donor #65932, Serial #8105091, Model #SGAV00 |
Recalling Firm/ Manufacturer |
Cryolife Inc 1655 Roberts Blvd Nw Kennesaw GA 30144-3632
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For Additional Information Contact |
Mr. P. Tyler Cochran, CQA, CTBS 770-419-3355
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Manufacturer Reason for Recall |
CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter on/about May 6, 2004. |
Quantity in Commerce |
4 units |
Distribution |
Nationwide, Austria, Canada, Germany |
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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