Events

Recall of Device Recall Baylis Medical LumbarCool Pain Management System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baylis Medical Corp *.

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
    55693
  • Event Risk Class
    Class 2
  • Event Number
    Z-1755-2010
  • Event Initiated Date
    2010-05-12
  • Event Date Posted
    2010-06-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91583
  • 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
    probe, radiofrequency lesion - Product Code GXI
  • Reason
    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
  • Model / Serial
    Lot Number: LKFA160310
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: TX
  • Product Description
    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 *
  • Manufacturer Address
    Baylis Medical Corp *, 5959 Trans-Canada Hwy, Montreal Canada
  • Source
    USFDA