Events

Recall of Device Recall InterX 5002, Sport, 1000, & Personal Sport packaged with Triad Alcohol Wipes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Neuro Resource Group 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
    58255
  • Event Risk Class
    Class 2
  • Event Number
    Z-2105-2011
  • Event Initiated Date
    2011-02-07
  • Event Date Posted
    2011-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98823
  • 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
    Stimulator, nerve, transcutaneous, for pain relief - Product Code GZJ
  • Reason
    Product package contains alcohol prep pads recalled by triad group because the prep pads have the potential to be contaminated with an objectionable organism.
  • Action
    Triad Group issued a press release on 2/7/2011, and notified consignees by e-mail 3/2/2011. Neuro Resource Group, Inc. ( NRG ) removed the recalled Triad wipes from all kits in house and obtained non recalled wipes from an alternate supplier. For replacement wipes customers may contact NRG customer service at 1-877-314-6500.

Device

Device Recall InterX 5002, Sport, 1000, & Personal Sport packaged with Triad Alcohol Wipes
  • Model / Serial
    All lots of the alcohol wipes.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and Inter x Personal Sport packaged with Triad alcohol wipes. The alcohol wipes manufactured by the Triad Group were labeled under brand names Triad, Select, Select Medical Products, PSS Select or PSS World Medical Inc. || Alcohol wipe is provided as a cleaning convenience for device electrodes.
  • Manufacturer
    Neuro Resource Group Inc

Manufacturer

Neuro Resource Group Inc
  • Manufacturer Address
    Neuro Resource Group Inc, 1100 Jupiter Rd Ste 190, Plano TX 75074-7047
  • Source
    USFDA