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U.S. Department of Health and Human Services

Class 2 Device Recall Urologix Targis

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  Class 2 Device Recall Urologix Targis see related information
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
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.
PMA Database PMAs with Product Code = MEQ and Original Applicant = Urologix, LLC
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