Date Initiated by Firm |
September 10, 2003 |
Date Posted |
October 15, 2003 |
Recall Status1 |
Terminated 3 on May 06, 2004 |
Recall Number |
Z-1296-03 |
Recall Event ID |
27280 |
Product Classification |
Heart-Valve, Allograft - Product Code MIE
|
Product |
CryoValve, Aortic & Conduit |
Code Information |
Donor #69884, Serial #8062335, Model #AV00. |
Recalling Firm/ Manufacturer |
Cryolife Inc 1655 Roberts Blvd Nw Kennesaw GA 30144
|
For Additional Information Contact |
Sylvie L. Verdon 770-419-3355
|
Manufacturer Reason for Recall |
Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter on 09/10/2003 and 09/12/2003. |
Quantity in Commerce |
1 unit |
Distribution |
The tissues were distributed to one hospital in CA and one physician in MN. |
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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