Class 1 Device Recall GlideScope Titanium SingleUse Video Laryngoscope

• Date Initiated by Firm: January 29, 2016
• Date Posted: March 11, 2016
• Recall Status: Terminated on March 01, 2017
• Recall Number: Z-1035-2016
• Recall Event ID: 73014
• Product Classification: Laryngoscope, rigid - Product Code CCW
• Product: 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.
• Code Information: LOT Number ranges: -LoPro S3: 081814 - 093015; -LoPro S4: 081114 - 090315; -MAC S3: 080814 - 101315; -MAC S4: 022514 - 082115
• Recalling Firm/ Manufacturer: Verathon, Inc.; 20001 N Creek Pkwy; Bothell WA 98011-8218
• For Additional Information Contact: Verathon Customer Care; 800-331-2313
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• 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).
• Quantity in Commerce: 7733 units (6377 units in the US and 1356 units International)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.