Events

Recall of Device Recall Iontophoresis active electrode

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Selectivemed Components 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
    31453
  • Event Risk Class
    Class 2
  • Event Number
    Z-0799-05
  • Event Initiated Date
    2005-03-15
  • Event Date Posted
    2005-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37924
  • 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
    Device, Iontophoresis, Other Uses - Product Code EGJ
  • Reason
    The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.
  • Action
    The recalling firm sent a recall letter, dated 3/15/05 to their consignee.

Device

Device Recall Iontophoresis active electrode
  • Model / Serial
    Lot #251478-003
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalling firm distributed the product to one consignee (distributor): North Coast Medical Inc., 18305 Sutter Blvd., Morgan Hill, CA 95037.
  • Product Description
    Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments.
  • Manufacturer
    Selectivemed Components Inc

Manufacturer

Selectivemed Components Inc
  • Manufacturer Address
    Selectivemed Components Inc, 564 Harcourt Rd, Mount Vernon OH 43050-3920
  • Source
    USFDA