Events

Recall of Device Recall Surgical Headlight

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gulf Medical Fiberoptics, 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
    58983
  • Event Risk Class
    Class 2
  • Event Number
    Z-0831-2012
  • Event Initiated Date
    2011-05-13
  • Event Date Posted
    2012-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100769
  • 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
    Light, surgical, fiberoptic - Product Code FST
  • Reason
    Gulf medical fiberoptics, inc. recalled their surgical headlight because the cleaning instructions for the exterior surfaces of the headlight , headgear and fiber cable with 70% isopropyl alcohol had not been validated.
  • Action
    On May 16, 2011, Gulf Medical Fiberoptics, Inc. issued to all customers an updated letter to their May 13, 2011 "Field Correction of Instructions For Use" informing them to discontinue the use of 70% isopropyl to clean the surfaces of the device. Enclosed with the letter was an updated Surgical Headlight User Guide with instructions to discard/shred/recycle the prior guide. The firm asked customers to return a form acknowledging the receipt and action from the letter. Customers with questions should contact Customer Service department manager Jacqueline Armand at 813-855-6618 ext. 427.

Device

Device Recall Surgical Headlight
  • Model / Serial
    Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, GMF-H106.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, including the states of FL, WI, WA, AL, CA, MO, MI, OH, VA, CO, TX, TN, NC and the countries of Turkey, Brazil, Belgium, South Korea, Panama, Mexico, Ireland, Taiwan (ROC), Italy, Argentina, India, Spain, Germany, and Venezuela.
  • Product Description
    Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.* Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and GMF-H106. The Surgical Headlight is a passive luminaire. It is illuminated by a source of light by way of the fiber optics and provides supplemental lighting for medical and surgical procedures.
  • Manufacturer
    Gulf Medical Fiberoptics, Inc.

Manufacturer

Gulf Medical Fiberoptics, Inc.
  • Manufacturer Address
    Gulf Medical Fiberoptics, Inc., 448 Commerce Blvd., Oldsmar FL 34677
  • Manufacturer Parent Company (2017)
    Gulf Medical Fiberoptics, Inc.
  • Source
    USFDA