Date Initiated by Firm |
March 16, 2007 |
Date Posted |
April 05, 2007 |
Recall Status1 |
Terminated 3 on May 25, 2007 |
Recall Number |
Z-0720-2007 |
Recall Event ID |
37638 |
PMA Number |
P970008 |
Product Classification |
Microwave Delivery System - Product Code MEQ
|
Product |
Urologix Microwave Delivery System 3.0 - 5.0. For use with prostatic urethra lengths of 3.0-5.0 cm only. Model TA1121D. |
Code Information |
Individual Catheter lot numbers: M002671,M002672, M002589 and M002736 for model TA1121D. Kit box lot numbers: KP011206, KP053006B, KP053006C, KP060205, KP0011206. |
Recalling Firm/ Manufacturer |
Urologix, Inc. 14405 21st Ave N Minneapolis MN 55447-4685
|
Manufacturer Reason for Recall |
The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.
|
FDA Determined Cause 2 |
Other |
Action |
A letter dated 3/16/07 was FedEx overnight to consignees. The letter described the product, problem and gave instructions for returning and replacing the affected product. |
Quantity in Commerce |
96 |
Distribution |
Nationwide and the Netherlands. |
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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PMA Database |
PMAs with Product Code = MEQ and Original Applicant = Urologix, LLC
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