Events

Recall of Disposable Detachable Monopolar Needle Electrode for EMG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Chalgren Enterprises 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
    56183
  • Event Risk Class
    Class 2
  • Event Number
    Z-2446-2010
  • Event Initiated Date
    2007-04-12
  • Event Date Posted
    2010-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92881
  • 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, needle, diagnostic electromyograph - Product Code IKT
  • Reason
    Sterility compromised-- investigation found that individual packaging seals were separating, which may compromise sterility.
  • Action
    Chalgren Enterprises, Inc. removed all of the affected inventory from inventory and had all affected inventory retrieved from distribution.

Device

Disposable Detachable Monopolar Needle Electrode for EMG
  • Model / Serial
    Lot number P059
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: USA states of CA, IL, NJ, OH and TX.
  • Product Description
    Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA.
  • Manufacturer
    Chalgren Enterprises Inc

Manufacturer

Chalgren Enterprises Inc
  • Manufacturer Address
    Chalgren Enterprises Inc, 380 Tomkins Ct, Gilroy CA 95020-3631
  • Manufacturer Parent Company (2017)
    Chalgren Enterprises Inc
  • Source
    USFDA