Events

Recall of Device Recall Cloth electrodes with Carbon construction

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by NAImco Inc dba Richmar 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
    63927
  • Event Risk Class
    Class 2
  • Event Number
    Z-0815-2013
  • Event Initiated Date
    2009-11-30
  • Event Date Posted
    2013-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115045
  • 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, cutaneous - Product Code GXY
  • Reason
    Electrode socket terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
  • Action
    Rich-Mar sent "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" letters to affected customers beginning on 11/30/2009. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 423-648-7730 ext. 214 for questions relating to t his recall.

Device

Device Recall Cloth electrodes with Carbon construction
  • Model / Serial
    All Serial Numbers distributed between 11/01/2009 and 01/31/2010
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of GA and TN.
  • Product Description
    Cloth electrodes with Carbon construction: || P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2" x 2" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 || P/N 201-1241, Cat Nos.: 201-124, 202-455, 203-340, 203-674, and 400-872, 2" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 || P/N 201-1251, Cat Nos.: 201-138, 202-276, 202-456, 203-336, 203-680, and 400-879, 3" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 || P/N 201-1381, Cat Nos.: 201-126, 203-678, and 400-856, 2" x 3.5" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 || P/N 201-1501, Cat Nos.: 201-150 and 400-863, 1.25" Round Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 || P/N 201-1521, Cat No. 400-852, 3 x 5 Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 || P/N 201-1541, Cat Nos.:201-154 and 400-865 1.5 x 2.5 Oval Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 || Cutaneous electrode.
  • Manufacturer
    NAImco Inc dba Richmar Inc

Manufacturer

NAImco Inc dba Richmar Inc
  • Manufacturer Address
    NAImco Inc dba Richmar Inc, 4120 S Creek Rd, Chattanooga TN 37406-1021
  • Source
    USFDA