Events

Recall of Device Recall The GlideScope Video Laryngoscope GVL 3, 4, 5 and AVL 2, 3, 4 and 5

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
    65129
  • Event Risk Class
    Class 1
  • Event Number
    Z-1558-2013
  • Event Initiated Date
    2013-05-08
  • Event Date Posted
    2013-06-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117940
  • 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
    Verathon glidescope reusable gvl and avl blades are being recalled due to the potential risk of premature failure/breakage of the blade tip that may not be readily visible during routine inspection before or after intubation.
  • Action
    Verathon issued an Urgent - Safety Alert and Medical Device Recall letter, dated May 10, 2013, to all affected customers The letter identified the affected product, problem and actions to be taken. The letter advises customers to discontinue the use of the specific serial numbers listed in the letter and asked that the affected product be returned to Verathon for replacement. The customers are also directed to fill out a return response form (included in the letter) regarding this recall. Consignees with questions are directed to contact their Verathon representative or Verathon Customer Care at 800-331-2313 (US and Canada) and 1-425-867-1348 for those consignees outside of US and Canada. the support team will be available Monday through Friday from 6 AM - 5 PM PST for the US and from 6 AM to 4:30 pm PST outside the US. Alternately they can e-mail Verathon at customerservice@verathon.com

Device

Device Recall The GlideScope Video Laryngoscope GVL 3, 4, 5 and AVL 2, 3, 4 and 5
  • Model / Serial
    Model, Part and Serial Numbers: Model # GVL 3, Part # 0574-0007, Serial # range MD112388 to MD121908; Model # GVL 4 Part # 0574-0001 Serial # range LG112759 to LG122582; Model # GVL 5 Part # 0574-0030 Serial # range XL111799 to XL121759; Model # AVL 2 Part # 0574-0118 Serial # range AC111500 to AC121604; Model # AVL 3 Part # 0574-0115 Serial # range AD111500 to AD121688; Model # AVL 4 Part # 0574-0116 Serial # range AE11150 to AE121778; and Model # AVL 5 Part # 0574-0117 Serial # range AF111500 to AF121666.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of : AK, AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Washington DC, Guam, and countries of : Argentina, Australia, Brazil, Canada, China, Ecuador, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Japan, Malaysia, Panama, Peru, Philippines, Singapore, South Korea, Taiwan, Thailand, The Netherlands, United Kingdom, and Venezuela.
  • Product Description
    GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades || Product Usage: 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. The GlideScope Video Laryngoscopes system should only be used by individuals who have been trained and authorized by a physician or the institution providing patient care. The device is not life sustaining or life supporting. The GlideScope AVL Video Monitor system has the same intended use as the GVL System. The difference between systems is that the AVL has a digital platform and the GVL an analog platform.
  • 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