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
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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
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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
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