Z-1174-2010

UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long Microwave Catheter (4.5+...

Name: Z-1174-2010 UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long Microwave Catheter (4.5+...
Creator: Urologix, Inc.
Published: 2010-02-18
License: https://open.fda.gov/license/

Urologix, LLC / initiated 2010-02-18 / Terminated / root cause: labeling and UDI

FDA source

Urologix, Inc. began a recall of 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... on 2010-02-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1174-2010
Status: Terminated
Initiated: 2010-02-18
Posted: 2010-03-19
Terminated: 2012-03-08
Recalling firm: Urologix, LLC
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.
Product code: MEQ System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
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
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: 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

Product code MEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)