Events

Recall of Device Recall Greenlight II laryngeal scope handle and cartridge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vital Signs Colorado 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
    57464
  • Event Risk Class
    Class 2
  • Event Number
    Z-1024-2011
  • Event Initiated Date
    2010-12-20
  • Event Date Posted
    2011-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96283
  • 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
    Laryngoscope, rigid - Product Code CCW
  • Reason
    Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination.
  • Action
    Healthcare Systems sent an URGENT MEDICAL DEVICE CORRECTION letter dated December 20, 2010, to all affected consignees advising them of the possible problem and giving them interim safety instructions until new battery cartridges were available. Customers were instructed to complete and return the Confirmation Form which was included with the letter. For information regarding this recall call 973-956-5300.

Device

Device Recall Greenlight II laryngeal scope handle and cartridge
  • Model / Serial
    Lot numbers; 5113Q, 5113R, 5113T, 5125Y, 5128F, 5129J, 5137P, 5139M, 5140P, 5144A, 5154V, 5154X, 5154Y, 5158K, 5161J, 5176T, 5180Z, 5182D, 5183L, 5184U, 5191X.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KY, MA, MN, MO, NH, NJ, NY, OH, OK, SC, TN, TX, WA, and WV and the countries of Australia, Belgium, Canada, Dominican Republic, Ecuador, Germany, Hong Kong, Latvia, New Zealand, Taiwan, Turkey, and the UK
  • Product Description
    Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs Colorado, Inc., 11039 E. Lansing Circle, Englewood, CO 80112. || Used for tracheal tube intubations during anesthesia, intensive care, and emergency medical airway management.
  • Manufacturer
    Vital Signs Colorado Inc.

Manufacturer

Vital Signs Colorado Inc.
  • Manufacturer Address
    Vital Signs Colorado Inc., 11039 East Lansing Circle, Englewood CO 80112-5909
  • Source
    USFDA