Events

Rappel de Urologix Targis System, Coolant Bag

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Urologix, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    58695
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2710-2011
  • Date de mise en oeuvre de l'événement
    2011-04-28
  • Date de publication de l'événement
    2011-06-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99976
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Sustem, hypertheria, rf/microwave (benign prostatic hyperplasia), thermotherapy - Product Code MEQ
  • Cause
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Urologix, Inc., 14405 21st Ave N, Minneapolis MN 55447-4685
  • Source
    USFDA