Events

Recall of Device Recall 9195371DS Lithrotripsy Probe LotLDS12516

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Northgate Technologies, 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
    77367
  • Event Risk Class
    Class 2
  • Event Number
    Z-0073-2018
  • Event Initiated Date
    2017-05-24
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155847
  • 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
    Lithotriptor, electro-hydraulic - Product Code FFK
  • Reason
    The inner and outer labels on the product contain incorrect reference number of 9-202-3751ds. according to northgate technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. could delay care.
  • Action
    Northgate Technologies sent an Urgent Medical Device Recall Notification dated May 24, 2017. Instructions included to examine records and locate affected devices, cease distribution or use and quarantine any affected products, return any affected product to Northgate, and contact customers if the affected product has been further distributed. For further questions, please call (800) 348-0424.

Device

Device Recall 9195371DS Lithrotripsy Probe LotLDS12516
  • Model / Serial
    Model No. 9-195-371DS, Lot/Serial Number LDS12516
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the following states : MA, NE and TN and Internationally to Canada.
  • Product Description
    Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
  • Manufacturer
    Northgate Technologies, Inc.

Manufacturer

Northgate Technologies, Inc.
  • Manufacturer Address
    Northgate Technologies, Inc., 1591 Scottsdale Ct, Elgin IL 60123-9361
  • Manufacturer Parent Company (2017)
    Trudell Medical Limited
  • Source
    USFDA