| Class 2 Device Recall |  |
Date Initiated by Firm | December 17, 2004 |
Date Posted | April 06, 2005 |
Recall Status1 |
Terminated 3 on June 01, 2005 |
Recall Number | Z-0683-05 |
Recall Event ID |
31140 |
Product Classification |
Heart-Valve, Allograft - Product Code MIE
|
Product | CryoValve, Aortic Valve & Conduit SG |
Code Information |
Donor #63601, Serial #7846205, Model #SGAV00 |
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 noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in their calculation. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified by letters dated 12/17/2004, 01/03/2005 and 01/19/2005. |
Quantity in Commerce | 1 tissue |
Distribution | CA, NJ, TX |
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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