Recall of GreenLine/D Laryngoscope Blades

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sun Med, 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
    50092
  • Event Risk Class
    Class 1
  • Event Number
    Z-0459-2009
  • Event Initiated Date
    2007-04-27
  • Event Date Posted
    2008-12-24
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2010-07-06
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Rigid laryngoscope - Product Code CCW
  • Reason
    A breakage problem of the acrylic bundles at both distal and proximal ends of the light tube for the md laryngoscope blade greenline d mac 3 has been detected. if breakage occurs during use, there is the potential for leaving approximately a one inch piece of acrylic tube in the patient's mouth.
  • Action
    SunMed sent initial recall letter on April 27, 2007 to all distributors requesting that kits containing the MacIntosh size 3, consisting of lots number Gj and Ha be returned to facility. Replacement information was included in letter. On December 12, 2008, the firm issued a Device Recall Press Release with additional information on the potential for the tube to break during use leaving an approximate 1 inch piece of the acrylic tube in the patients mouth and subsequently requiring medical or surgical intervention to prevent serous injury to the patient. SunMed has notified its distributors and customers by certified mail and has arranged for return and replacement of all recalled products. Consumers with question may contact their distributor of the GreenLine/D or SunMed at 1-800-433-2797.

Device

  • Model / Serial
    Lots: Gj, Ha
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Sun Med, Inc., 12393 Belcher Road, Suite 450, Largo FL 33773-3097
  • Source
    USFDA