Events

Recall of PlusRite Power Strike Metal Halide Lamps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fanlight Corporation 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
    35548
  • Event Risk Class
    Class 2
  • Event Number
    Z-0450-06
  • Event Initiated Date
    2006-03-24
  • Event Date Posted
    2006-06-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46373
  • 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
    unknown device name - Product Code U28
  • Reason
    These non-self-extinguishing mercury vapor and metal halide lamps failed to comply with the performance requirements of 21 cfr 1040.30 and the certification and identification requirements of 21 cfr 1010.2 and 1010.3.
  • Action
    1.Fanlight Corporation, Incorporated shall notify all dealers and purchasers requesting that the recipients forward a copy of the letter on to each recipient''s customers, with the objective of notifying as many end users as possible. Fanlight at no cost to the purchaser will bring the units into compliance

Device

PlusRite Power Strike Metal Halide Lamps
  • Model / Serial
  • Distribution
    Nationwide
  • Product Description
    PlusRite Power Strike Metal Halide Lamps
  • Manufacturer
    Fanlight Corporation Inc

Manufacturer

Fanlight Corporation Inc
  • Manufacturer Address
    Fanlight Corporation Inc, 14145 Proctor Ave Ste 14, City Of Industry CA 91746-2841
  • Source
    USFDA