Events

Recall of Urologix Targis System, Coolant Bag

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Urologix, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58695
  • Event Risk Class
    Class 2
  • Event Number
    Z-2710-2011
  • Event Initiated Date
    2011-04-28
  • Event Date Posted
    2011-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99976
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Sustem, hypertheria, rf/microwave (benign prostatic hyperplasia), thermotherapy - Product Code MEQ
  • Reason
    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.
  • 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.

Device

Urologix Targis System, Coolant Bag
  • Model / Serial
    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 Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Urologix, Inc.

Manufacturer

Urologix, Inc.
  • Manufacturer Address
    Urologix, Inc., 14405 21st Ave N, Minneapolis MN 55447-4685
  • Source
    USFDA