Events

Recall of Device Recall GlideScope GVL 2 Stat

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
    76642
  • Event Risk Class
    Class 2
  • Event Number
    Z-1852-2017
  • Event Initiated Date
    2017-03-03
  • Event Date Posted
    2017-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153718
  • 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
    Product labeled as gvl 2 stat (blades), lot gc32825, was physically packaged with the incorrect size device (gvl 1 stat (blades)).
  • Action
    Verathon provided a notification letter to their Canadian distributor on March 03, 2017, and distribution of the letter to the rest-of-the-world (ROW) foreign consignees was initiated on March 10, 2017. Verathon intends to send the Urgent Medical Device Recall Glidescope GVL2 Stat letter and Customer Response Form to US consignees by March 31, 2017. Consignees should quarantine and discard any affected product on site, and fill out the attached Recall Response Form and return it to Verathon by fax to (425) 883- 2896, or email to CSNotifications@verathon.com even if they do not have any Stats (blades) subject to the recall. Consignees who have any questions about this voluntary recall, please contact Verathon representative or Verathon Customer Care at (800) 331-2313 (U.S. and Canada). If consignees located outside of the U.S. or Canada, please call (425) 867-1348. Consignees can also send email to cservice@verathon.com.

Device

Device Recall GlideScope GVL 2 Stat
  • Model / Serial
    Lot GC32825
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA ( nationwide) and to the countries of : Canada, Chile, Mexico, Panama, Philippines, Qatar ,South Africa, and The Netherlands.
  • Product Description
    It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). || Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). || Part Number 0574-0027: GVL 2 Stat (single pouched Stat). || Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part number 0270-0429), is added as part of the kit.
  • 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