Events

Recall of Device Recall UltraThin LightMat Surgical Illuminator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lumitex 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
    52817
  • Event Risk Class
    Class 2
  • Event Number
    Z-1998-2009
  • Event Initiated Date
    2009-07-01
  • Event Date Posted
    2009-09-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84064
  • 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
    Retractor, fiberoptic - Product Code FDG
  • Reason
    Adhesive which is used to attach lightmat to retractor may not have been tested to medical standards. the vendor provided an adhesive strip that did not conform to lumitex specifications. the adhesive strip provided may not have met lumitex requirements to be medical grade, eto compatible, and biocompatible.
  • Action
    Lumitex, Inc. issued a recall letter dated July 2, 2009 to their Customers describing the affected device and requesting its return. For further information, contact Lumitex, Inc. at 1-440-243-8401.

Device

Device Recall UltraThin LightMat Surgical Illuminator
  • Model / Serial
    Model Number: UA2550; Lot Number: I01161.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to the following states: CA, FL, KS, MA, ME, MI , NC, NM, NV, NY, OH, and TX.
  • Product Description
    Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550, Exp Date: 2012-05. Product is packaged in individual sterile pouch w/5 pouches per box. || The LightMat is intended for the illumination of surgical procedures, particularly where deep cavities or adjacent tissues limit outside light in the surgical field.
  • Manufacturer
    Lumitex Inc

Manufacturer

Lumitex Inc
  • Manufacturer Address
    Lumitex Inc, 8443 Dow Cir, Strongsville OH 44136
  • Manufacturer Parent Company (2017)
    Lumitex
  • Source
    USFDA