Date Initiated by Firm | July 01, 2004 |
Date Posted | July 22, 2004 |
Recall Status1 |
Terminated 3 on September 03, 2004 |
Recall Number | Z-1135-04 |
Recall Event ID |
29501 |
Product Classification |
Heart-Valve, Allograft - Product Code MIE
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Product | CryoValve, Conduit and Pulmonary Valve |
Code Information |
Donor Number: 72560, Serial Number: 8178422, Model Number: PV00 |
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 |
Manufacturer Reason for Recall | The sterilization cycle for the instruments used during the procurement of the tissue from the donor had expired. |
FDA Determined Cause 2 | Other |
Action | The physicians were notified by letter on 07/01/2004. Both tissues were reported implanted. |
Quantity in Commerce | 1 unit |
Distribution | CA, 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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