Events

Rappel de Device Recall Baylis Medical LumbarCool Pain Management System

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 Baylis Medical Corp *.

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
    55693
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1755-2010
  • Date de mise en oeuvre de l'événement
    2010-05-12
  • Date de publication de l'événement
    2010-06-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91583
  • 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
    probe, radiofrequency lesion - Product Code GXI
  • Cause
    Name of the device reflected on the product packing sleeve is incorrect.
  • Action
    The firm, Baylis Medical, notified US Distributor by email and sent a "URGENT Field Corrective Action Notice" dated May 12, 2010, to customer. The notifications described the product, problem and action to be taken by customer. The customers were given the follow options: Option 1: In order to prevent confusion in identification of the product before use, please immediately remove and dispose the package sleeve that covers the tray packaging of the LumbarCool Pain Management Kit. Option 2: Alternatively, you may exchange your kit from Lot LKFA160310 with a correctly labeled replacement LumbarCool Pain Management Kit by contacting Kimberly-Clark Health Care sales representative. The customers were ask to fill out the Field Corrective Action Acknowledgment and return it. Any question please call Baylis Sales Representative at 905-602-4875 and/or contact your local sales representative for any further information you may require.

Device

Device Recall Baylis Medical LumbarCool Pain Management System
  • Modèle / numéro de série
    Lot Number: LKFA160310
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: TX
  • Description du dispositif
    The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalogue Number: LUK-17-150-4 || The LumbarCool Pain Management System, a cooled radiofrequency pain management system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for use to create RF lesions in nervous tissue.
  • Manufacturer
    Baylis Medical Corp *

Manufacturer

Baylis Medical Corp *
  • Adresse du fabricant
    Baylis Medical Corp *, 5959 Trans-Canada Hwy, Montreal Canada
  • Source
    USFDA