Events

Recall of Device Recall Harris Medical UV Lamp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Harris Medical Resources.

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
    55724
  • Event Risk Class
    Class 2
  • Event Number
    Z-1808-2010
  • Event Initiated Date
    2010-05-13
  • Event Date Posted
    2010-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91667
  • 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
    Medical ultra-violet (UV) Lamp - Product Code MXG
  • Reason
    The harris uv lamp was promoted for sub-lingual treatment of hiv/aids; hepatitis b; hepatitis c; malaria, typhoid, amoeba infections and other blood diseases. the product was marketed without a 510(k), or an approved application for premarket approval (pma) or an approved application for an investigational device exemption (ide). questions are directed to the firm at 773-583-7500.
  • Action
    Urgent Device Recall letters were sent registered, certified mail, return receipt requested, to the direct accounts on 5/13/10 - 5/18/10. The accounts were informed that Harris could make no claims as to the safety or efficacy of the Harris Medical UV Lamp in their possession and could recommend no medical indications for use because the necessary regulatory filings have not been completed and reviewed by the FDA, and that Harris Medical has no approved investigation clinical trials underway for the Harris Medical UV Lamp. The accounts were requested to check their inventory and quarantine any Harris Medical UV Lamps they may have in their possession and return them to Harris Medical using the enclosed pre-paid UPS shipping label. If the accounts further distributed the device, they were instructed to sub-recall them to the user level. The accounts were also requested to complete and return via mail or fax the enclosed return response form acknowledging the receipt and understanding of the recall letter and indicating the disposition of the devices. Any questions were directed to Thomas Perez at the company, at 773-583-7500.

Device

Device Recall Harris Medical UV Lamp
  • Model / Serial
    All models, serial numbers and lot numbers are subject to this recall.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Florida, Hawaii, Ohio, Texas and internationally to Canada, Dominican Republic, Israel, Kenya and Peru
  • Product Description
    Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or manufacturer, packer or distributor. It is packaged with a "Harris UV Lamp Training Manual"
  • Manufacturer
    Harris Medical Resources

Manufacturer

Harris Medical Resources
  • Manufacturer Address
    Harris Medical Resources, 3535 W Irving Park Rd, Chicago IL 60618-3219
  • Source
    USFDA