Events

Recall of Device Recall HealthPort BioAnologics Patient Electrode Sensor Test Kit,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vermed, 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
    58052
  • Event Risk Class
    Class 2
  • Event Number
    Z-2136-2011
  • Event Initiated Date
    2011-02-08
  • Event Date Posted
    2011-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98120
  • 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
    Patient electrode sensor kit - Product Code IKD
  • Reason
    Vermed kits contain a product component (triad alcohol prep pads) recalled due to potential bacillus cereus contamination.
  • Action
    Vermed sent consignee a recall notification letter on February 8, 2011, followed by a phone call and email. The consignee was instructed to respond with a Recall Reply Form via fax and to notify any customers to whom the affected product was further distributed. All recalled alcohol prep pads were to be returned to Triad Group. Firm is replacing Triad alcohol pads in kits with pads from another supplier and has removed Triad from its approved vendor list. For questions regarding this recall call 802-722-9976.

Device

Device Recall HealthPort BioAnologics Patient Electrode Sensor Test Kit,
  • Model / Serial
    4 lots affected: 198459, Exp. 02-2012; 200026, Exp. 03-2012; 203031, Exp. 08-2012; 204885, Exp. 12-2012
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    OR
  • Product Description
    HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25 kits/carton || Each kit contains 100 tab electrodes and 26 alcohol pads. The electrodes are used to measure bodyfat analysis. The alcohol pads (non-sterile) are used for cleaning the skin to help the electrodes adhere better. There are no instructions for use with the kit.
  • Manufacturer
    Vermed, Inc.

Manufacturer

Vermed, Inc.
  • Manufacturer Address
    Vermed, Inc., 9 Lovell Dr., Bellows Falls VT 05101
  • Manufacturer Parent Company (2017)
    Nissha Co. Ltd.
  • Source
    USFDA