Date Initiated by Firm | September 10, 2003 |
Date Posted | October 15, 2003 |
Recall Status1 |
Terminated 3 on May 06, 2004 |
Recall Number | Z-1297-03 |
Recall Event ID |
27280 |
Product Classification |
Valve, Pulmonary - Product Code NJK
|
Product | CryoValve, Pulmonary Valve & Conduit |
Code Information |
Donor #69884, Serial #8062341, Model #PV00. |
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 |
|
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.
|