Z-2710-2011

The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured for: UROLOGIX, Inc...

Name: Z-2710-2011 The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured for: UROLOGIX, Inc...
Creator: Urologix, Inc.
Published: 2011-04-28
License: https://open.fda.gov/license/

Urologix, LLC / initiated 2011-04-28 / Terminated / root cause: manufacturing process

FDA source

Urologix, Inc. began a recall of The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured for: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN... on 2011-04-28. The reason FDA records is "Urologix is recalling certain lots of Targis System Coolant Bag devices distributed over a two week period. The devices are packaged into disposable Procedure Kits containing a microwave catheter, a Coolant Bag and a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2710-2011
Status: Terminated
Initiated: 2011-04-28
Posted: 2011-06-30
Terminated: 2012-04-26
Recalling firm: Urologix, LLC
Product: The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured for: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. UROLOGIX, CTC Advance Short, (2.5-3.5 cm), PT1034, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. CTC Advance Standard , (3.0-5.0 cm), PT1036, Sterile EO,, Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. CTC Advance Long, (4.5+ cm), PT1038, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. Targis Standard, (3.0-5.0 cm), PT1013, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. The Urologix Targis system is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethral lengths greater than 2.5 cm.
Product code: MEQ System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
Reason for recall: Urologix is recalling certain lots of Targis System Coolant Bag devices distributed over a two week period. The devices are packaged into disposable Procedure Kits containing a microwave catheter, a Coolant Bag and a RTU Plus balloon. The reason for this Recall involves three lots of Coolant Bags that contain an increased risk of leakage of water at the Sensor Module. This leak is detectabl
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urologix, Inc. sent an "IMPORTANT RECALL INFORMATION" letter dated April 28, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs the customers to identify the affected kit lots, remove the Coolant Bag pouch(s) and to complete and return a Return Material Authorization form with the product(s). Additionally, an enclosed Customer Acknowledgement Form should be completed and faxed to 763-475-1443. Customers with questions should contact the Director of Regulatory and Quality at 763-475-1400.
Quantity in commerce: 119
Distribution: Nationwide Distribution--including the states of AL, CA, CO, FL, GA, MA, MI, MN, NJ, NY, OR, PA, TN, WV, and including Puerto Rico.
Product codes and lots: Catalog # / Lot No. PT1034 / AHP0333111A, AHP040411A, AHP040411B, AHP040611A, AHP040711A, AHP040811A, AHP041211A PT1036 / ACP033011B, ACP040111A, ACP040111B, ACP040611A, ACP040711A, ACP040711B, ACP040811A, ACP041211A PT1038 / ALP033111A, ALP040411A PT1013 / KP040711A CA1111B / C900284, C900285 and C900286 C900284, C900285 and C900286 C900284 and C900285 C900285

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)