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U.S. Department of Health and Human Services

Class 2 Device Recall UROLOGIX CTC Advance" Standard Microwave Catheter

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  Class 2 Device Recall UROLOGIX CTC Advance" Standard Microwave Catheter see related information
Date Initiated by Firm February 18, 2010
Date Posted March 19, 2010
Recall Status1 Terminated 3 on March 08, 2012
Recall Number Z-1174-2010
Recall Event ID 54703
PMA Number P970008 
Product Classification System, hyperthermia, rf/microwave (benign prostatic hyperplasia), thermotherapy - Product Code MEQ
Product UROLOGIX¿ CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long Microwave Catheter (4.5+ cm), CTC Advance" Short Microwave Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU Plus Handle, Sterile EO, Manufactured by UROLOGIX¿, INC, 14405 Twenty-First Avenue North, Minneapolis, MN 55447.

The CTC Advance" catheters and RTU Plus are used as part of the Targis¿ System.

Each disposable device is packaged on a card inside a heat sealed pouch. Each Kit Box then hold 3 product pouches: 1 catheter, 1 coolant bag and 1 RTU Plus balloon. The RTU Plus Kit contains 3 RTU Plus Handles packaged in separate sterile pouches.
Code Information KIT LOT NUMBER:  ACP011610D, ACP011710E, ACP011810F, ACP011910G, AHP01810D, AHP011210A, AHP011310B, AHP012310C, AHP012510C, AHP012710C, ALP012510B, and RH00252  CATHETER LOT NUMBERS:  091226MCA1, 091228MHA1, 091229MCA1, 091229MCA2, 091229MHA1, 09123MCA1, 091230MHA1, 100105MHA1, 100106MHA1, 100106MHA2, 100111MHA1, 100111MHA2, 100111MHA3, 100112MLA2, 100113MHA1, 100113MHA2, and 100114MHA1  RTU PLUS LOT NUMBERS:  Handle =RH00252, Balloon= RB0781 & RB0783
Recalling Firm/
Manufacturer		 Urologix, Inc.
14405 21st Ave N
Minneapolis MN 55447-4685
For Additional Information Contact
763-475-1400
Manufacturer Reason
for Recall		 Urolgix¿ is recalling certain lots of CTC Advance" catheters and RTU Plus devices which are integral components of the Targis¿ System. The reason for this Recall is a labeling error only; the issue involves a discrepancy in the"Use Before" date printed on the product label. In the affected lots, the "Use Before" date , commonly known as the expiration date, is printed as 2012-12 when it should r
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Consignees were sent a UROLOGIX " Important Recall Information" letter dated February 18, 2010. The letter was addressed to the client's name. The letter described the problem and product involved. It provided Instructions for "Returning and Replacing Affected Product" and requested the return of the "Customer Acknowledgement Form". If you have questions, please call (763)-475-1400.
Quantity in Commerce 154
Distribution AL, AZ, CA, FL, IN, MI, MN, MS, NY, OK PA, TN, TX, and WI.
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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