Date Initiated by Firm |
December 10, 2003 |
Date Posted |
February 25, 2004 |
Recall Status1 |
Terminated 3 on July 23, 2004 |
Recall Number |
Z-0548-04 |
Recall Event ID |
28345 |
Product Classification |
Heart-Valve, Allograft - Product Code MIE
|
Product |
CryoValve Pulmonary Valve and Conduit |
Code Information |
Donor #29640, Serial #6194362, Model #PV00 (Pulmonary Valve) |
Recalling Firm/ Manufacturer |
Cryolife Inc 1655 Roberts Blvd Nw Kennesaw GA 30144-3632
|
For Additional Information Contact |
Mr. P. Tyler Cochran 770-419-3355
|
Manufacturer Reason for Recall |
As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.
|
FDA Determined Cause 2 |
Other |
Action |
The consignee was notified by letter on 12/10/2003. CryoLife received confirmation of receipt of the notification from the physician who reported the tissue was implanted on 04/17/1997. |
Quantity in Commerce |
1 unit |
Distribution |
The allograft was shipped to one physician in 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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