Events

Recall of Device Recall GlideScope Titanium SingleUse Video Laryngoscope

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Verathon, 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
    73014
  • Event Risk Class
    Class 1
  • Event Number
    Z-1035-2016
  • Event Initiated Date
    2016-01-29
  • Event Date Posted
    2016-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142740
  • 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
    The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when glidescope titanium su laryngoscope blades are in use. video "flickering" appears as the intermittent break-up of the on-screen video image, appearing as either distorted horizontal or vertical bars of displaced video signal.
  • Action
    The firm, Verathon, began mailing the "URGENT: MEDICAL DEVICE RECALL" GLIDESCOPE VIDEO LARYNGOSCOPE TITANIUM SINGLE-USE BLADES letter to their consignees on January 29, 2016. The letter describes the product, problem and actions to be taken. Verathon will instruct the company's foreign distributors to communicate the Customer Recall Letter to their international customers. Verathon has contracted with a business services company, Stericycle, to coordinate the initial consignee communications in the United States, Australia and Canada. Stericycle will send the Customer Recall Letters, and conduct consignee follow-up communications for return of the Recall Response Forms. Verathon will replace all affected GlideScope Titanium Single Use (SU) blades that remain in your facility's inventory with new product that has been passed the enhanced screening test for video flickering. Customers were advised to take the following actions: -Fill out the attached Recall Response Form and return it to Verathon by fax (888) 943-5170, or email, verathon5165@stericycle.com. Please return the form even if you do not have any blades subject to the recall. If consignees need to expedite a product replacement contact Verathon representative or Verathon Customer Care at (800) 331-2313 (U.S. and Canada). The firm has live agent support Monday through Friday from 8:00am to 5:00pm Eastern Time. Consignees can also send email to CCTechSupport@verathon.com. Consignees who have any questions about this Product Recall, please contact Verathon representative or call (888) 943-4207 (U.S. and Canada) or send email to verathon5165@stericycle.com. Please report any suspected malfunction or adverse event related to any GlideScope Video Laryngoscope devices to Verathon Customer Care at the telephone numbers above and to FDA's MedWatch Program (1-800-FDA-1088 or www.fda.gov/medwatch).

Device

Device Recall GlideScope Titanium SingleUse Video Laryngoscope
  • Model / Serial
    LOT Number ranges:  -LoPro S3: 081814 - 093015; -LoPro S4: 081114 - 090315; -MAC S3: 080814 - 101315; -MAC S4: 022514 - 082115;
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Luxembourg, Saudi Arabia, Singapore, Spain, Sweden, The Netherlands, U.A.E., and United Kingdom.
  • Product Description
    GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. || The system incorporates a high-resolution, full-color digital camera and monitor for real-time viewing and recording. || Affected Product Names and Part Numbers: || -LoPro S3: 0574-0130 (single blade) or 0270-0769 (box of 10) || -LoPro S4: 0574-0131 (single blade) or 0270-0770 (box of 10) || -MAC S3: 0574-0132 (single blade) or 0270-0771 (box of 10) || -MAC S4: 0574-0133 (single blade) or 0270-0772 (box of 10) || The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.
  • Manufacturer
    Verathon, Inc.

Manufacturer

Verathon, Inc.
  • Manufacturer Address
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Manufacturer Parent Company (2017)
    Roper Technologies Inc
  • Source
    USFDA