Events

Recall of FC4000 microTargeting Electrode Kit 5x

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by FHC, 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
    50103
  • Event Risk Class
    Class 2
  • Event Number
    Z-0498-2009
  • Event Initiated Date
    2008-10-20
  • Event Date Posted
    2008-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74770
  • 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
    Electrode - Product Code GZL
  • Reason
    Mislabeled: may contain an electrode longer than labeled size.
  • Action
    FHC notified customers via an Urgent: Medical Device Recall letter dated 10/20/08 advising users to remove the recalled electrodes from inventory and set the product aside for inspection by your FHC representative. Customers were asked to document their actions by completing the enclosed form and faxing it back to FHC at 207-666-8539.

Device

FC4000 microTargeting Electrode Kit 5x
  • Model / Serial
    Lot number: 866051
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of CA, CO, FL, LA, NM, PA, TN, and PR.
  • Product Description
    FC4000 MicroTargeting Electrode Kit 5x || For use with Nexframe¿ and Nexdrive¿ || Distributed by Medtronic Inc., Minneapolis, MN || REF: FCH 4000 (5 Prefilled single use kits -5 packages and 2 electrodes each) || Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.
  • Manufacturer
    FHC, Inc.

Manufacturer

FHC, Inc.
  • Manufacturer Address
    FHC, Inc., 1201 Main Street, Bowdoinham ME 04008
  • Manufacturer Parent Company (2017)
    Fhc Inc.
  • Source
    USFDA